Services: Pharmaceutical

Strategic Consulting

Pharmaceutical Strategic Consulting

Whether it’s a corporate needs analysis, corporate growth/transformation initiative or due diligence/acquisition, Regulatory Compliance Associates (RCA®) worldwide experience can help ensure a successful mix of top-notch advice and people so your Pharmaceutical strategy is on time, and on budget — and you’re never embroiled in a costly mistake.

 

Our broad range of Pharmaceutical Strategic consulting services include:

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

Remediation Costs of Non-Compliance

remediation costs

The main regulatory standard for ensuring pharmaceutical quality is 21 Code of Federal Regulations (CFR) Parts 210 and 211, collectively referred to as the current good manufacturing practice (CGMPs) regulation for human pharmaceuticals. It’s not only the CGMP regulations that matter; the approaches biopharmaceutical companies take to interpret and embrace these regulations are of equal, if not more, importance. The remediation costs associated with CGMP non-compliance can be staggering to say the least.

 

CGMPs place emphasis on product quality and compliance with the regulations. So how do companies embrace, and even embody, quality and compliance with CGMPs? One way minimize remediation costs is to operate under a quality culture.  

 

Quality Culture

 

A company should have a pharmaceutical quality system as described in FDA Guidance for Industry, Q10 Pharmaceutical Quality System. A quality culture is created when managers believe a company has a duty to create a mutually beneficial relationship between itself, its employees, and its customers.

 

Culture is the shared beliefs, values, attitudes, and behavior patterns that characterize a family, a community, or an organization. A healthy organizational culture is rooted in the understanding that quality is good for the company and its customers. Thus, its existence is a driving force behind how employees act and behave regardless of level, title, or decision-making authority.

 

FDA Form 483

 

In defining a set of Six Sigma values for a corporate culture, the core principles should include integrity, customer focus, and people. This type of quality culture begins with company leaders who believe in the necessity of serving customers in order for their organizations to succeed. Six Sigma is a widely accepted methodology to help reduce remediation costs. 

 

FDA conducts several types of inspections to help protect consumers from unsafe products: pre-approval inspection, routine inspections of a registered facility, and “for-cause” inspections. After FDA completes an inspection, company management may receive an FDA Form 483 when an investigator(s) has observed any conditions that, in their judgment, may constitute violations of the Food Drug and Cosmetic (FD&C) Act, related acts, and applicable sections of 21 CFR 210 and 211.

 

FDA Warning Letter

 

Observations are made when, in the FDA investigator’s judgment, conditions or practices observed would indicate that product has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.

 

FDA Form 483 notifies the company’s management of objectionable conditions. Companies respond to the 483 in writing with their corrective action plan and implement schedule. The 483 is closed when the company receives their establishment inspection report (EIR). Unfortunately, there are companies that either do not follow through on their commitments or they do so too slowly. If circumstances merit, FDA can choose to escalate the potential for remediation costs by serving the company with a warning letter.

 

CAPA

 

Typically, FDA gives individuals and companies an opportunity to take voluntary and prompt corrective action before the agency initiates an enforcement action. The primary goal of a CAPA system is to introduce new procedure(s) that address requirements for the corrective actions that return an organization to compliance. Additionally, a FDA warning letter is the principal means of notifying regulated companies of violations and corrective actions needed.

 

The following factors are often used to determine whether to issue a warning letter: 

 

  • The firm’s compliance history (e.g., a history of serious violations, past remediation costs or repeated failure to prevent the recurrence of violations)
  • The nature of the violation (e.g., a violation that the firm was aware of [was evident or discovered] but failed to correct
  • The product risk and the impact of the violations on such risk
  • The overall adequacy of the firm’s corrective action and whether the corrective action addresses the specific violations. Remediation costs also may include related violations, related products or facilities, and contains provisions for monitoring and review to ensure effectiveness and prevent recurrence
  • Whether documentation of the corrective action was provided to enable the agency to undertake an informed evaluation
  • Whether the timeframe for the corrective action is appropriate and whether actual progress has been made in accordance with the timeframe.

 

Consent Decree

 

When a company repeatedly violates cGMP requirements, FDA can force it, through legal channels, to make specific changes. Under this severe form of escalation by FDA, the objective is no longer a discussion about responses to 483s or warning letter observations, it’s about a forced company make-over. This process, known as consent decree, exposes all broken systems within a company.

 

FDA does not care about any efforts and expenses undertaken by the company to redesign and implement a robust quality management system; a common element of a consent decree is demonstrating sustainability. A company under consent decree who doesn’t demonstrate sustainability can lose future revenue in different ways. One way, which is particularly difficult to quantitate, is the price of “lost innovation”. The company is redirecting revenue into compliance, oversight, and remediation instead of reinvesting it into research and development of new products. 

 

Consent Decree Definition

 

As previously mentioned, Sustainability is one of the primary drivers for defining an organization’s capacity to know when it is veering off course. The consent decree definition of the program is critical to making the correct decisions, taking appropriate actions, and maintaining a state of control without future external intervention.

 

Sustainability embraces the core quality culture values and expected behaviors of integrity, empowerment, and accountability.  A consent decree mandates a series of annual inspections performed by a third-party to monitor sustainability. FDA recommends companies hire external experts and invest time and money to inspect and certify compliance, often for many years.

 

Operating under a consent decree is a dire situation for the company and one where there is no certain predictability of the outcome. To understand the full magnitude of a consent decree’s impact, one needs to take into consideration the many and various modes in which the negative consequences can be realized (see Figure 1).  

 

costs
Figure 1: Overview of different repercussions
to and reverberations from a pharma company
operating under consent decree. (Image courtesy of author)

 

Remediation Costs of Non-Compliance

 

This discussion focuses on three ways to look at the costs of non-compliance:

 

  • Quantifiable costs
  • Difficult-to-quantify costs
  • Invisible costs with hidden impacts

 

Quantifiable Costs

 

Quantifiable costs are those that can have a value assigned to them with a reasonable degree of accuracy. Quantifiable costs are usually more obvious, but they manifest in several ways as shown in Figure 1.

 

A major requisite term of a consent decree is for the company to retain, at its own expense, an independent third-party for ongoing certification and oversight of the implementation of agreed to corrective action. Another requirement may be a commitment to have every released batch certified to be CGMP. 

 

At Will Employment

 

At Will Employment is defined as an indefinite period of time of employment that may be terminated either by employer or employee. It is not uncommon that firing an employee or/and replacement of multiple employees is a step associated with a consent decree. The training and retraining costs can often be difficult to quantify in the short term until compliance improves. This company action is meant to set the tone internally that the non-compliant way of doing business will no longer be tolerated. 

 

FDA Violation Penalties

 

FDA can levy significant violation penalties in the form of fines for not meeting action dates. Examples include $15,000 per day for missed dates, royalty payments up to 24.6% per product not revalidated on time, and costs for FDA inspections. Furthermore, the US Treasury can garnish profit from sales through fines. Such was the case for Wyeth, who agreed to a consent decree regarding its Marietta, PA and Pearl River, NY facilities. FDA inspections of these facilities found several GMP deviations that eventually resulted in warning letters.

 

One of the largest drug safety settlements occurred when generic-drug manufacturer, Ranbaxy USA Inc., a subsidiary of Indian generic-pharmaceutical manufacturer Ranbaxy Laboratories Limited, pleaded guilty to felony charges relating to the manufacture and distribution of certain adulterated drugs made at two of Ranbaxy’s manufacturing facilities in India (3). Ranbaxy paid a criminal fine and forfeiture totaling $150 million and settled civil claims under the False Claims Act and related state laws for $350 million.

 

Civil Monetary Penalties Law

 

Entering into consent decree can also expose a company to civil penalties. Depending on the circumstances, shareholders, patients, and sometimes even company employees may be able to sue for damages.

 

One such law suit arose from an unsuccessful effort by Baxter International to fix problems with its Colleague Infusion Pump. Westmoreland County Employee Retirement System (Westmoreland) alleged that Baxter’s directors and officers breached their fiduciary duties by “consciously disregarding their responsibility to bring Baxter into compliance with the 2006 consent decree and related health and safety laws”. 

 

FDA Recall

 

The Baxter breach was alleged to have caused the organization to lose more than $550 million after FDA mandated a recall of the Colleague Infusion Pumps. Baxter invested time and money trying to fix the pumps, but the manufacturing problems persisted over time.

 

FDA invoked its power under the original consent decree by ordering Baxter to recall and destroy all Colleague Infusion Pumps then in use in the US. This is where invisible costs with hidden impacts turn into the customer reimbursement for the value of the recalled device. Invisible costs also included Baxter being required to assist in finding replacement devices for those customers impacted.  The company’s stock price fell by more than 4% after the announcement and the company later recorded a pre-tax charge of $588 million to account for the estimated costs of the recall. 

 

Drug Shortage

 

When a drug manufacturer subject to enforcement action is the sole supplier of an important medicine, drug shortages become a concern. Short-term solutions may include doctors substituting medications that may have lesser efficacy. Pharmaceutical companies with potential manufacturing capability may be incentivized by FDA to manufacture identical or equivalent drug products; however, medium-to-long lead times can delay product availability. When supplies dwindle, patients must pay higher prices for the same drug. 

 

One illustration of this scenario is the FDA consent decree with Genzyme regarding repeated manufacturing issues at the company’s Allston, MA facility. The consent decree included an up-front disgorgement of past profits of $175 million and the requirement to move fill/finish operations out of the Allston plant by a specific date.  Had Genzyme not met those deadlines, FDA could have required the company to disgorge 18.5% of revenue for the affected products. 

 

Difficult-to-Quantify Costs

 

Other financial ramifications from consent decrees may be difficult to quantify. For example, some employees may lose their confidence in the commitment or ability of the company’s CEO and other executives to manage the situation.

 

Employee Attrition

 

Employee attrition is expected, but if the exodus includes long-tenured employees the company may be drained of valuable knowledge and talent. The longer the situation exists, the more difficult it becomes to retain the best employees.

 

Reputation Damage

 

A company under a consent decree is subject to reputation damage, which can be accentuated by the ease of publicly available negative media coverage about how the company operated. Negative media coverage can result in public fear. In the Ranbaxy case, an import ban had been in place for 30 drugs manufactured at two of its Indian manufacturing plants resulting from alleged data falsification.  This type of information can result in public concerns that medicines could be adulterated.

 

Batch Release

 

Lost revenue due to the company’s inability to sell product can also be an issue. Companies under consent decree experience long delays in releasing product due to the intensive oversight required, when a batch fails release testing, and when a product is recalled. The cost for the logistics of product recall and destruction can be high, especially if the API is expensive or has a long lead time.

 

Group Purchasing Organizations

 

Another potential cost is the inability to sell a product. Group purchasing organizations (GPOs) use the power of collective purchasing to buy pharmaceuticals at discounts. An underlying premise is continuity of supply; if a pharmaceutical manufacturer is unable to deliver the product contracted, the GPO must obtain replacement product from the open market, often at a higher price. GPOs wary of a potential inability of the company to supply its products may consider other sources.

 

In one of the largest settlements to date, Ranbaxy pled guilty to felony charges.  The charges were manufacturing and distributing adulterated drugs made at the Indian manufacturing sites. The criminal fine and forfeiture totaled $150 million and another $350 million in remediation costs to settle civil claims under the False Claims Act.

 

Invisible Costs and Hidden Impacts

 

If the remediation costs to bring a facility under consent decree into CGMP compliance is determined to exceed the company’s financial ability or it makes no financial sense to continue operations, the company’s management may decide to close the facility. Shuttering a facility, can have devastating impact on the local community, particularly in rural areas where the manufacturer is a primary employer. The community’s tax base will also suffer.

 

The company can lose its competitive edge because its busy focusing inside rather than externally. This can be a competitive advantage to your closest competition looking for a way in which to leverage your situation for their benefit.  The potential opens for the company to become alienated and therefore lose rank compared to its direct competitors.

 

A company can also be denied approval of new drug while non-compliance exists (4).  Because of its consent decree, approval of two new drugs by Eli Lilly was delayed. This was the result of CGMP issues being found during pre-approval inspection in the fall of 2001, which was six years after its consent decree.

 

Conclusion

 

The collective cost of remediation of non-compliance far exceeds the remediation cost to remain in compliance. The number of consent decrees issued per year has remained consistent during the past decade. However, companies have found it difficult to extricate themselves from the agreements.

 

As a result, the number of companies under consent decrees at any given time has increased. Generally, it takes many years for a company to demonstrate that it is in full compliance. Only one company that has received a decree in the past 10 years has met all requirements and had the decree lifted.

 

Considering the fines and the payments to the third-party consultants, the remediation costs associated with a consent decree can become very high and have a significant effect on a company’s profit. It is estimated that the costs incurred by Warner-Lambert for a consent decree–in terms of product terminations, delays in approvals, and bringing facilities and systems into compliance–was nearly $1 billion. The Warner Lambert fine was only $10 million, a small percentage of the total cost. Schering-Plough’s initial fine was $500 million. Abbott Laboratories has spent almost $1 billion resulting from a consent decree issued, including a fine of approximately $100 million.

 

About the Article

 

 

Pharmaceutical Technology
Vol. 41, No. 11
Pages: 54–57

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

Pharma Product Launch & Lessons Learned

When medical or pharma product launch failure happens the field, everyone suffers—not just the patient, but also the manufacturer and its employees, investors, suppliers, and even competitors. No one wants a product failure, least of all the company liable for its safety.

Faced with a crisis, the manufacturer has three priorities:

  • Protect patients;
  • Resolve the problem as quickly as possible
  • Prevent the problem from recurring.

Any number of product failures can threaten a huge loss of value, above and beyond liability, to the manufacturer. If investors lose confidence and share price falls, enterprise value is destroyed. Then, as the company dedicates resources to resolving the problem, their other jobs—such as new product development—don’t get done (or, at best, don’t get done as quickly).

 

Product Failures

Pharmaceutical Innovation

Since innovation is the beating heart of the medical products and pharmaceutical industries, any delay of a new product launch can cost a manufacturer millions; in these industries, time really is money. All the more reason that speed is so important in fixing any product problem.

Yet, many—maybe most—companies are not really prepared for product failures because they lack a crisis playbook. Without a scenario-based guide, they begin and often conduct an investigation in a somewhat helter-skelter fashion, wasting valuable time figuring out what to do first, and next, and after that.

Crisis Management

The optimal time to answer those “what to do” questions is before a crisis, not in the middle of one. In our work, helping companies investigate and resolve product failures, Regulatory Compliance Associates® and The Science Cooperative have gained the following insights about what works (and what doesn’t) in managing a product crisis.

Pharma Product Launch Problems

A problem is identified as serious when field events reach some specified tipping point that indicates a trend beyond isolated incidences. At that time, the company’s leadership team has to make a few decisions: Should an official notice be released? Should the product be recalled? If yes, which markets? Should production of the product be stopped? In multiple or select plants?

Prompt action generally contributes to good will and positive publicity. The challenge at this stage is a deficit of facts since the forensic investigation itself hasn’t started. In putting together a crisis playbook, a company should begin with guidelines and policies to direct the first responders in evaluating the size of the threat and the appropriateness of various options for response depending on the apparent scope and severity of the problem.

Supply Chain

For example, if a product is one component in an assembly, perhaps the best response is for multiple supply chain owners to work together to find the optimal fix for the problem. The “point man” for making that happen could be decided in advance.

Of course, a crisis playbook would also help business leaders evaluate the cost of alternative responses. Scenario-based planning provides a context for weighing alternatives and options. Above all else, the first responders would want to stop patient harm. Every manufacturer we have worked with has agreed: protecting the safety of the patient population comes first.

Pharma Product Launch Teams

After the first responders have reviewed the situation and decided there is cause for escalation, it is time to identify a crisis manager, an investigation leader and the functional forensic team(s). In our experience, an attorney or senior executive with strong project management skills is a good choice for crisis manager. Also, each team needs at least one member with strong organizational skills.

The crisis playbook should cover roles and responsibilities—including potential action checklists—for multiple functional teams. It is feasible that a crisis might require teams in R&D, sciences, manufacturing, distribution, supply chain, human resources, legal, regulatory, quality, environmental, sales/marketing, and communications, as well as subteams for representatives from affected countries and from government affairs.

Crisis Playbook

What expertise would each team require? What would be each team’s scope and focus? Most important, how should the teams interact, coordinate activities, and measure progress toward milestones and a final resolution? A crisis playbook should provide answers, which would vary case-by-case. (See the sidebar, “Functional Crisis Planning: Roles and Responsibilities for the Crisis Team”). The crisis playbook should cover roles and responsibilities – including potential action checklists – for multiple functional teams.

Good project management skills are fundamental to managing the investigation process effectively and efficiently. Although the teams are all working on the same problem, each has its own agenda and requires its own plan and milestones. Role-based accountability for project and team-specific organization, documentation, schedules, data management, and reporting can be decided well in advance of a crisis.

In our experience, it is a best practice for the leaders of the crisis management team to meet daily and assure clear, timely, cross-functional communication, as well as to agree on next steps.

Pharma Product Launch: Crisis Roadmap

If valuable resources are taken away or distracted from their jobs to any significant degree, real and measurable enterprise value is destroyed. While leaders and experts from each affected corporate function play a vital role in an investigation, it is a smart business strategy to bring in specialists to support the effort with their expertise and experience.

FDA Investigation

In addition to minimizing damage to the company’s value and brand, the quick building up of expertise also speeds up the forensic process itself. One of our clients asked both the FDA and the notified body for its European markets to participate in an investigation. As a result, the company tripled its lab capacity and bolstered its credibility with shareholders and the marketplace at large.

Independent consultants can add muscle to an investigation, while buttressing investor confidence. As an added benefit, they can often give employees the freedom to speak without repercussion because they’re beyond the “politics” of the enterprise. Also, outside resources with the right knowledge and “know how” will be well-versed in Corrective and Preventive Action (CAPA) processes and can use this expertise to streamline and speed up the investigation.

Pharma Product Launch New Direction

pharma product launchEach team needs a directed course of action based on scenario planning. Given a set of regulatory variables that would vary by product and case—including (but not limited to) the severity of the crisis, geography, financial liability, and the possibility of substitute products—what steps should each team take to contribute to the problem identification, resolution, and ongoing prevention?

The steps required of each team can be captured in “punch lists” to minimize redundancy and duplication of effort. Then, it is relatively easy to assign responsibility for each item on the list. If the product is used in more than one country or region, the work of the corporate teams needs to be mirrored by local teams. And everyone’s findings need to roll up to the top.

Deviations

Perhaps one of the most critical points in the investigation roadmap—and the one that is most often missing—is a “stop” point. The longer an investigation goes on, the more enterprise value it can destroy. In the beginning, it’s important to decide: when is the problem solved? Is it when the contaminant is found? When the deviations in the factory or the supply chain process is fixed? Or when the product is reintroduced to the market?

Among these inquiries is another with implications for continuous improvement: why didn’t the QA processes in place (for design, manufacturing, and other functions) detect the potential failure? Scope control is a fundamental component of good project management. In most cases, there is no need to parse the product failures problem beyond a practical solution.

Crisis Checklist

The crisis playbook should include prototype action plans, checklists, work streams, decision processes, schedules, milestones, resource requirements, budgets, and documentation (see the sidebar, “Steps for Post-Crisis Resolution”).

Pharma Product Launch Communication

From day one, the crisis manager needs to share information about commitments, expectations, and progress. Communication—internally with employees and externally with investors, supply chain partners, regulatory agencies, the public, and sometimes competitors—is critically important.

Crisis Communication

The overall process needs a “point person” for communication, as does each team, whether at the corporate or facility level. The role of each communication channel—including press releases, internal newsletters or briefs, media contacts, video, and letters to shareholders and the investment community—can be planned well in advance: a crisis playbook can take chaos out of the process and enable the company to put its best foot forward.

In communication, the current best practice is a dedicated portal, a single source for real-time updates on the investigation, typically accessible through the company’s website. The old proverb “a stitch in time saves nine” captures the value of a crisis playbook: being prepared will save time and money down the road.

Key Steps in Crisis Management

Most importantly, fewer product failures could literally save lives. By being mindful of the components of effective and efficient crisis management—building up and deploying expert resources; coordinating and integrating parallel work streams; following and documenting rationalized processes—a company’s leadership can be confident in its preparedness to handle a product failure to the satisfaction of everyone’s best interests.

pharma product launch

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

Manufacturing and Facility Support

Manufacturing and Facility Validation Services

Whether you are building a new facility or expansion to your existing operations; installing new capital equipment; re-validating existing equipment / utilities or you have been challenged with compliance deficiencies with your manufacturing operations/equipment, facility or utility, turn to the experts at Regulatory Compliance Associates® Inc. We can develop and tailor the appropriate cGMP validation program to help.

 

We perform an array of validation services, such as:

  • We can assist with the entire validation life cycle continuum—starting with the validation strategy/validation master plan through purchase, qualification, and commissioning
  • We have cGMP experts that can help and guide you from design qualification, and user requirement definition through factory/site acceptance and through commissioning and qualification. We have experts in user requirement specification (URS), drug specification (DS), factory acceptance test (FAT), site acceptance test (SAT), and installation qualification / operational qualification/process qualification (IQ/OQ/PQ) summary reports
  • Expertise in the validation of: equipment, facilities, utilities, computer systems, and controls supporting the areas of manufacturing, laboratory, utilities, and processes
  • Comparability protocols and re-validation of existing equipment and operations
  • Remediation of quality system deficiencies related to your laboratory, manufacturing process, equipment, or facility

 

Our broad range of Pharmaceutical Quality Assurance consulting services include:

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

FDA Inspections: Hope is Not a Strategy

Subject matter experts from Regulatory Compliance Associates® Inc. discuss how too many organizations scramble when an FDA inspection occurs because they fail to be adequately prepared. True inspection preparedness, however, supplements internal audits with a practiced inspection process and focused behavioral training.

 

 

Internal Audit

 

While internal audits are a key component of inspection preparedness, they tend to be informal, less intense, and more focused on auditing than inspecting. True inspection preparedness supplements internal audits with a practiced inspection process and focused behavioral training for key personnel.

 

Before a FDA inspection occurs, organizations should have an inspection process in place and conduct mock inspections. Like any process, inspection readiness needs a plan that is executed, assessed, and continuously improved upon. 

 

Roles & Responsibilities 

 

The Inspection Room (Front Room) 
While inspectors often walk the facility, the inspection room provides a meeting space to review documentation and answer questions from the inspectors. In this “front room,” system owners or subject matter experts (SMEs) review and present materials to the FDA inspector. 

 

The Control Room (Back Room) 
The control room provides the documentation, interviewees, and preparation that is needed to support the inspection process. This “back room” team processes requests for information, retrieves documents from electronic systems, and also triages documents as needed. The control room is staffed with quality and technical personnel who log requests for information and alert department heads within the organization. 

Control room personnel should always:

  • Conduct a minimum of two reviews of every document prior to sending it to the inspection room:
  • Quality Review:
    • Make sure it points to valid SOPs and Work Instructions, etc.
  • Technical Review:
    • Make sure the SMEs have reviewed and are prepared to speak to the process with the inspector
  • Have back-up printers, toner, copiers and paper on hand

Some organizations appoint runners to take the data back and forth between the control room and inspection room. There are technology solutions to operationalize the inspection process as well. 

 

Behavioral Training

 

In the past, employees were often trained to give curt answers to FDA inspectors to avoid inadvertent revelations to the agency. This approach created fear and mistrust among employees, and set up adversarial relationships with FDA staff. In order to create the most beneficial inspection process environment, however, both the agency and the company need to form a partnership. Key behavioral tips for success include:

 

  • Empower the inspection and control room teams.
  • Bring SMEs into the control room to help gather data, review documents, and consult on the answer before they are summoned to the inspection room.
  • Help SMEs understand their role in the bigger picture of the inspection. Prep them on related questions that have already been asked.
  • Don’t allow an SME to bring in notes or an uncontrolled document.
  • Use the control room to debrief SMEs after meetings with the inspector.
  • Anticipate and prepare. The language used in inspector requests can provide insights. Anticipate next questions, proactively pull documents, and understand related metrics. For example, if the inspector asks about CAPA, review related documents such as open CAPAs, high-risk CAPAs, the average length of time for CAPAs, and the longest time for open CAPAs. Be prepared to answer the inspector’s next questions.

Practicing the inspection process, however, can be one of the best ways to help employees learn appropriate behaviors and response techniques. Train employees to:

 

  • Focus on the question asked; restate the question when unsure of what’s being asked.
  • Readily admit to not knowing an answer, but provide a date and time when the answer will be provided.
  • Create an environment that reinforces the positive but recognizes weaknesses, such as “we understand this is an area for improvement,” rather than “this has been a problem for a long time.”
  • Recognize the need for training across the organization on inspection readiness. Consider off-site locations as well. The FDA inspection process starts when the FDA inspector pulls up into the parking lot and interfaces with reception and security personnel. Don’t limit inspection training to just inspection and SME personnel.

 

Mock Inspections

 

Many companies conduct internal audits as part of their inspection readiness strategies. Mock inspections, however, take the next step and allow companies to actually practice the inspection room, the control room, and inspector interaction. 

 

During mock inspections, organizations set up inspection rooms and control rooms to help teams learn how to readily access documentation that would potentially be requested during an inspection. Additionally, these practice sessions give employees an opportunity to demonstrate proper behavior and interviewing techniques when working with the regulatory agency. 

 

A mock inspection can also be used to probe further on issues uncovered during internal audits. The mock Inspection team should bring in SMEs and other personnel as needed for this activity. This approach helps the organization fully understand areas needing improvement, and gives them a platform to take corrective action before the agency actually arrives.

 

Being properly prepared for inspection ensures that the inspection process will run smoother, decreases the likelihood of observations, and helps groom the organization and individuals for higher levels of future performance. 

 

Published by:

 

 

 

Medical Device and Diagnostic Industry.

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

GMP Manufacturing

When it comes to pharmaceutical manufacturing, ensuring a strong quality culture is one way to avoid recurring GMP issues, such as data integrity. Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, and 2022 PDA Board of Directors Chair outlined the evolution of current quality culture initiatives and showcased some tools to help organizations build quality culture into GMP manufacturing operations during the Nov. 11, 2021, Redica Systems Quality Week webinar, “Past, Present, and Future of Quality Culture.”

 

“I think that is what we see sometimes in our industry,” she said. “We do not remember how we got some of the regulations that exist today, and we repeat our past mistakes.”

 

From Quality Metrics to Quality Culture

 

Schniepp began her presentation with a look at how quality culture evolved from the early 2010s discussion on quality metrics. Key points included the following:

 

  • On Oct. 5, 2005, CDER Director Janet Woodcock directed pharma manufacturers to build “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drug products without extensive regulatory oversight.” This set in motion CDER’s emphasis on quality in manufacturing.
  • Then, in 2012, the U.S. Congress passed the FDA Safety and Innovation Act (FDASIA). Title VII of the Act allows for risk-based inspection of manufacturing sites, including requesting records in advance, or in lieu of an inspection. Additionally, the Act requires the FDA to provide Congress with an annual report on the state of drug shortages.
  • Around the same time that FDASIA became effective, drug shortages became a critical concern for the agency. Schniepp pointed to aging facilities as one reason for shortages. “Tangential to metrics and quality culture, we had aging facilities, i.e., facilities producing many of the drugs showing up on the drug shortage list were degrading and not being maintained.” Quality issues at these sites had become apparent and potentially causing shortages.
  • In 2014, FDA proposed implementation of a quality metrics system to encourage adoption of quality-supporting practices.

 

GMP Manufacturing & Measuring Quality Culture

 

The quality metrics push resulted in a series of conferences by ISPE, PDA, and the Brookings Institution (Figure 1 below).

 

“One of the elements that came out of all of these discussions was the fact that you could request any metrics that you wanted. What FDA proposed initially was rejection rate on batches, CAPA rates, etc., but the conversation became that without the culture of the organization being assessed, you could not really count on the data. So, that is how [quality metrics and quality culture] tie together,” Schniepp explained.

 

Quality Metrics

 

“You needed to have a functioning, efficient, quality metric system that gives you reliable data. And you have to count on the integrity of the culture of an organization in order to have confidence in the data that it sends you. Off of that, the discussion turned to, ‘well, how do you measure quality culture?’”

 

GMP Manufacturing & Quality Culture Behavior

 

Schniepp was part of a PDA team studying the relationship between quality culture behavior and mature quality attributes to see if there was a set of mature quality attributes that could serve as a surrogate for quality culture behaviors (ISPE has also done work in this area). 

 

“’Mature quality attribute’” refers to “those things in your quality management system (QMS) such as your CAPA program, your change control, your investigations procedures, how you report deviations, how you record batch rejection rates, i.e., all of those things are in your quality culture or in your QMS.”

 

Quality Attributes

 

But her team wanted to know if mature quality attributes related to the behaviors of employees and management correlated with company culture, such as do people feel comfortable speaking up, do they talk to management about their concerns, do they understand their jobs, etc. The team’s research resulted in what Schniepp refers to as “the Culture Equation” (Figure 2).

 

regulatory compliance
Figure 2

 

“The foundation of this is quality attributes that are quantifiable and easily measured, provided they equal quality behaviors,” she said. “In other words, you have attributes reflected in your behaviors that then define your quality culture. So, if quality cultures equal quality behaviors equals quality culture, your quality attributes equal quality behaviors equal quality culture. If you can measure your quality attributes, you can define your quality culture.”

 

Operational Excellence

 

By surveying PDA’s membership, her team gathered enough data to conduct statistical analysis and was able to determine there is a relationship between quality culture behavior and quality attributes. They then worked with another team from the University of Saint Gallen’s operational excellence program. That team also found a correlation confirming “quality attributes equal quality behaviors equal quality culture.” 

 

The PDA and St. Gallen research resulted in the PDA Quality Culture Guided Assessment Tool, addressing five key areas in which companies should focus in order to build quality culture: Employee Ownership and Engagement, Continuous Improvement, Technical Excellence, Leadership Commitment, and Communication and Collaboration. This tool is currently under development as a PDA standard.

 

Quality Metrics, Data Integrity & Quality Culture

 

regulatory compliance

Figure 1

 

Data integrity is increasingly connected with quality culture. In the PIC/S guidance, Good Practices For Data Management And Integrity in Regulated GMP/GDP Environments, “they have defined quality culture, and they have given us a little bit of information about how management can create a work environment—a culture—that is transparent and open.” 

 

Schniepp also pointed to three other documents:

  • UK MHRA GxP Data Integrity Definitions and Guidance for Industry
  • WHO Guidance on Good Data and Record Management Practices
  • FDA guidance Data Integrity and Compliance With Drug CGMP Questions and Answers

 

“In their regulations, regulators are starting to define and link culture to data integrity violations,” she explained.

 

Data Integrity

 

She then provided a real-life example of a data integrity violation caused by a company’s culture.  

 

“This one is kind of an interesting one because it was really an attempt by management to encourage employees to do a good job, but what they did created integrity violations.”

 

A contract manufacturing organization (CMO) set a GMP manufacturing goal to release batch records to clients within 30 days of manufacturing the product. To encourage this, management dangled the carrot of a pizza party at the end of the year if this goal was met. In order to meet this goal, employees released batch records to clients even if investigations had not uncovered the root cause. Investigations would be prematurely closed and then reopened after the batch record had been sent to the client. 

 

“That, in and of itself, is a data integrity nightmare,” Schniepp said. “Can you imagine explaining in an audit by a regulator, ‘well, we wanted a pizza party?’”

 

GMP Manufacturing & Organizational Culture

 

Regarding deviation investigations, she told another story of a company for whom she worked that involved repeat observations. When reviewing deviations, she found that one operator had 30 deviations tied to him involving a specific product. This operator failed to sign the batch record during a specific point in time in manufacturing. His managers kept retraining him. 

 

[Author’s Note: Additional information about deviation investigations can be found in the articles, “GMP Inspection Case Study Focuses on Inadequate Deviation Investigations” and “How to Avoid Three Common Deviation Investigation Pitfalls.”]

 

Batch Records

 

In talking with the operator, Schniepp learned that in order for the operator to sign the batch record (according to GMP regulations at that particular point in manufacturing), the operator had to leave the product alone in the equipment, de-gown, sign the batch record, re-gown, and return, all the while hoping the product was okay. Out of concern for the product, the operator chose to stay behind and try to remember to sign the batch record once he was done.

 

“It was a poorly designed batch record process,” she said. But the operator did not feel listened to when he brought his concerns to management.

 

GMP Labeling

 

Schniepp then pointed out that other employees worked on the product under the same cGMP constraints. So, what were these other employees doing? How many other data integrity violations occurred? Was GMP labelling reviewed accurately?

“Nobody else was bringing it up. If you do not have that open culture, if you are not encouraging people to speak up and you are not listening to them, you do not have a good quality culture.”

 

The Future is GMP Manufacturing Quality

 

For further evidence of the importance of GMP certification and quality culture, Schniepp reviewed a 483 observation issued in 2019 with numerous examples of data mismanagement. The company in question then responded to FDA with a letter promising to ensure a robust quality culture going forward. [Author’s Note: For more about this GMP compliance incident, read the first case study in the article, “Data Integrity Concerns Discovered in Gene Therapy Product Submissions,” by Jerry Chapman.]

 

FDA 483

 

Schniepp believes this 483 observation shows FDA’s intent to heavily focus more on good manufacturing practices in future inspections. This means companies must develop or enhance their quality culture when thinking about how to prepare for upcoming inspections. 

 

“I believe we will see more of this,” she said. “More companies will be looking at their GMP manufacturing and trying to improve the Quality Culture.”

 

Otherwise, as she explained at the beginning of her presentation, companies who remain in the past when it comes to cGMP certified practices that lead to quality culture face the prospect of 483 observations, Warning Letters, and other negative outcomes.

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.