Since the Pandemic became global in 2020, the FDA has been requesting documents from firms in advance of or in lieu of an inspection. This authority comes from the Federal Food, Drug, and Cosmetic Act (FD&C Act) in Section 704(a)(4). However, while they have not adopted doing FDA inspections remotely instead of an onsite inspection, they have stated publicly they are considering the possibility, and virtual audits have become very common.
FDA is still conducting onsite inspections and has submitted for new employee headcount in 2022 to reduce the existing backlog. Each inspection is carefully considered on a case-by-case basis where there is an imminent public health need. Factors such as risk to the FDA investigator and site personnel are also considered when determining if a virtual audit is appropriate.
Onsite inspections could be the standard inspection with the investigators staying in the facility the entire time or it could be a hybrid approach where the investigators spend some time in the facility and other time doing remote FDA reviews and conducting video interviews.
2022 will bring a new wave of inspections to the medical device and pharmaceutical industry. So how can you prepare in advance? And what does good look like from a virtual inspection process? Below are some thoughts for your team to consider.
FDA registrations simply don’t end and some health authorities outside the US have already done remote FDA inspections (e.g. the EMA). However, while the FDA has not done a true remote inspection, they have done many hybrid inspections.
What does an FDA inspection mean?
With the FDA format, regulatory authority tools include video chat for activities inside the interview room. They also use technology like secure shared online folders for offsite document review. Companies prepared to manage FDA inspections under this new method stand the best chance of success after an inspection to have fewer FDA 483 observations in general.
The FDA could start with a records request and then come onsite, or vice versa. Remember, if it is a true inspection the FDA must provide the most senior ranking person at the site a Notice of Inspection, Form FDA 482, at the very start of the inspection. If the Form 482 isn’t issued, then it is likely a records request utilizing their Section 704(a)(4) authorities.
FDA record requests should follow the process and guidance outlined in their internal Staff Manual Guide, SMG 9004.1 Policy and Procedures for Requesting Records In Advance of or In Lieu of a Drug Inspection. Think of the SMG as an internal procedure for the FDA. If you are curious you can find it at this link: Staff Manual Guide 9004.1 (fda.gov)
Bottom line, if the FDA’s request comes through a call or email then it is not an inspection. It is a records request and should follow the procedures in SMG 9004.1. If they show up onsite, present a Form 482, then it is an inspection. Then the inspection could stay all onsite or it could be a hybrid approach, as noted above.
Planning for an FDA Inspection
With the current pandemic, FDA has been providing a little advanced notice of the inspection, usually a few days to a week. The notice is directed less at giving companies time to prepare and instead intended to ensure the required personnel, who may be working offsite, are available. But prior planning precludes poor performance, so prepare well beforehand to manage a hybrid virtual inspection.
Some recommendations for inspection prep and readiness are as follows:
Determine who in the company will host the FDA inspection. Whether it’s onsite or virtual or hybrid you’ll want to designate a host. This distinction lets you train someone for the role, which helps streamline the process and eliminates last-minute challenges
Who will be the scribe and how will they take notes and communicate with the site team?
Determine who will step in as the back-up host and scribe in case the primaries are out sick.
Think through how the FDA inspection will flow, from the time it starts, through the facility tour, document requests and employee interviews.
If a virtual walk-through is conducted do you have sufficient Wi-Fi capabilities across the entire facility to avoid glitches in the audit and video.
How will you do the video? Use a phone camera or a real video camera.
Make sure you have the equipment ready to go and have tested it throughout the site.
How do you plan to maintain appropriate social distancing? Some companies have set up conference rooms complete with plexiglass barriers, tape markers on the floor and separated seating. In other cases, some activities are conducted outdoors, weather permitting.
Some additional helpful tips based on our experience with other clients are:
Collecting documents: This one can take a little time and it’s suggested that you start with the basics that you know the investigator will request, for example, a general site presentation, a batch record, deviation list, complaint list, facility layout, CAPA list, compliance documents, change controls and other master files.
Scanning and saving: Scan these documents ahead of time and upload them to an online company drive that is easily accessed by the inspection team.
Getting the right equipment: Whether you plan to use a smartphone or Wi-Fi camera, make sure the user knows how to operate it correctly and it works in every nook and cranny of your facility.
Running simulated inspections: A walkthrough lets you test video and audio quality. You can also identify and address poor Wi-Fi connectivity.
Virtual and hybrid inspections are a new format, and there can be challenges on both sides. Make sure your plan has some flexibility. Also, keep an eye on the FDA’s website for any announcements on virtual inspections. If the FDA does decide to start conducting virtual inspections it is likely that they will also roll out internal processes and procedures to ensure a harmonized approach. These items could be a Staff Manual Guide or a new chapter in their Investigations Operations Manual (Investigations Operations Manual | FDA).
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The world has changed in many ways since the outbreak of the global COVID-19 pandemic. Regulators are taking advantage of technology to institute greater social distancing, limiting contact between people to curb the spread of the coronavirus. For you, this could mean a transition to virtual audits.
The auditing process, which helps you identify and fix compliance deficiencies, must continue to maintain the vital supply chain of needed drugs and other items.
Approach a Virtual Audit
For some clients and suppliers, virtual audits may be a long-term solution. It may not be clear for some time how long COVID-19 precautions will need to stay in place. For parties that have well-established relationships and supply chains, virtual audits may make more sense over the long term.
The opportunity to reduce one-on-one interactions lessens the risk of spreading the coronavirus. If the two sides already have a level of comfort together, their ability to work through challenging times will be better than if you are embarking on a new relationship, where things might not go as smoothly.
Not everything can be accomplished virtually. You’ll still face some instances where an in-person visit is necessary, such as for pre-approvals and new products. Plan accordingly. Taking every possible precaution, such as requiring masks and gloves and keeping the auditor 6 feet away from employees, can protect both parties during such mandatory in-person interactions.
If you do not think an in-person visit is necessary or you’re dealing with extenuating circumstances, such as an outbreak of the virus, communicate your concerns. The well-being of your employees and the auditor should be the focus of any post-pandemic auditing strategy, and you can protect your employees by voicing any concerns you have.
Make Adjustments for the Long Term
Treatments are still being developed for the coronavirus, and it will take some time before the spread of the virus is under control. Until then, virtual audits will become a long-term solution to protect everyone involved and reduce the spread of infection.
You can learn from your initial experiences and make changes to help during the next virtual audit. Try these strategies for assistance with long-term planning:
Take notes during the virtual audit, observing anything that surprises you.
Keep track of any personal protective equipment needed if a brief in-person audit is used.
Speak with employees after the virtual audit to get their input on what went well and what could be improved.
Looking over your notes and results from past audits can also help you anticipate any potential issues or concerns before your first virtual audit. Remember that this is new territory for everyone and that you’ll likely encounter some bumps in the road as the processes get smoothed out. If you have any questions about virtual audits and how to prepare for them, get in touch with Regulatory Compliance Associates® today.
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.
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, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.
We also handle more medical device regulatory affairs consulting submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, MHRA, EMA and notified bodies worldwide. Therefore, you can count on RCA’s medical device regulatory consulting for in-depth and up-to-date insights which increase speed-to-market.
Let the RCA team of experts guide you through the constantly changing domestic and international regulations to successfully register your products. From pre-submission strategies to international submission support, our expert team has the unique insight necessary to help you take your products to the next stage of product development.
Follow the links below to learn more about our regulatory services in Pharmaceuticals and/or Medical Devices.
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].
Cell and Gene Therapies also known as (ETMPs) have continued to evolve in recent years. Over the last 15 years the industry and regulatory bodies have continued to learn more about them and in recent year there have been more and more guidance documents released outlining what the regulating bodies want the manufacturers and developers of these different biologic products to look for and adhere to during development.
Cell and Gene Therapies are Personalized medicine meaning, one patient, one drug. These types of drugs are not produced in large scale or in batches like the standard biologics or drugs we have been used to manufacturing up to this point. They are made in very small batches that are produced in laboratory setting but require the same environmental controls as your typical aseptic processing but a much smaller scale.
Issues with Approval
The issues companies face when manufacturing cell and gene is that they are introducing variability right away in the process in terms of the active ingredient. In this type of manufacturing, the active ingredient is the specific patient’s genome. With the variable ingredient, manufacturers do not know what they are working with upfront which makes the process difficult. It is a non-tradition way of thinking that makes validating a process that has that kind of variability hard on cell and gene companies without experience in this area.
The Non-traditional Approach
This approach to drug approval is based on an individualized patient’s genetic makeup and requires the developers to make a constant process of taking the patient’s genetic material and producing the cell and gene therapy dose at the end. Developers have to be able to categorize the variable, walk it through the process, and then categorize it again at the end making sure it is safe and effective for the patient even though it is based on their cell and gene genetic material.
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.
The industry of products containing cannabis or related products like CBD has become increasingly popular and more available. One of the main catalysts for this cannabis business trend was The 2018 Farm Bill. The Farm Bill allowed for the agricultural production, transport and possession of hemp products, with some serious restrictions. The bill requires hemp to contain 0.3 percent or less of THC (the compound that can produce mind-altering effects) and also creates additional rules around the production of hemp.
Nevertheless, since the passing of the Farm Bill and since a growing interest in legalizing cannabis at the state level, both for personal and medical use, the marketplace has seen a big growth in Cannabidiol (CBD) and marijuana-based products. Despite this, businesses and consumers alike remain confused about what is and is not permitted by law.
Part of the challenge is that a gray area can exist between regulatory agencies, federal rules and state laws. This can cause confusion. Regulatory agencies and states are especially concerned with how companies market their product, so even a legal product can run afoul of regulations.
Regulatory Trends
Right now, some of the parallels in this industry include:
FDA warning letters: The FDA is sending warning letters to businesses offering CBD and marijuana-based products in situations where unsubstantiated claims are made. The FDA is especially strict with products being classified as dietary supplements. In June 2019, for example, the FDA sent warning letters to Curaleaf, advising the company that its marketing does not comply with the Federal Food, Drug and Cosmetic Act.
New testing needs: Products with CBD need to be tested in controlled, clinical based studies if businesses want to establish and confirm claims. However, federal regulations listing marijuana as a schedule 1 substance make such tests legally challenging for many businesses. In addition, the rules for testing and compliance are constantly changing, creating added confusion about what is needed in terms of testing, reporting and compliance in general.
Some progress: In the industry, some are heartened by some signs of forward movement. The FDA did approve Epidiolex, a drug that contains CBD as a primary ingredient. The drug is used to treat Lennox-Gastaut syndrome or Dravet syndrome. The manufacturers of the medicine had to undergo testing and the approval process other drugs must undergo, so while the case sets the precedent that CBD and CBD-containing products can be classified as drugs, it does suggest manufacturers will need to undergo the same strict process.
Projected future regulations: In May 2019, the FDA held a public meeting to discuss the safety, manufacturing, marketing, sale and use of drugs and products with cannabis or cannabis-derived compounds as ingredients. The meeting allowed experts and the public to express opinions, concerns and requests. In addition, industry insiders say the Current Good Manufacturing Practice (CGMP) regulations set by the FDA for drugs will soon likely include updated guidelines for CBD-containing drugs.
Stay on Top of Trends
Regulatory Compliance Associates helps companies stay compliant with changing FDA regulations surrounding the cannabis business. Whether you are producing CBD products or want to expand your current line of products, we help resolve regulatory and quality challenges to ensure compliance, even in an environment where gray areas still exist. Contact us at Regulatory Compliance Associates today for support.
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 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.
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.
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.
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
Regulatory 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
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.
Click to watch Regulatory Compliance Associates medical device consultant, Dr. Stephen Coulter, discuss the common tools & processes used during product development. Early stages of new product development include analyzing user needs & translating design benefits into long-term patient efficacy.
Developing an original product idea is difficult but many common tools & processes are consistently used. The early stages of product development include analyzing user needs and how those translate into design inputs.
Product Development Strategy
Ideation and product development life cycle research can help you identify user needs. Additionally, increasing the quality of an existing product is often a successful new product development strategy. Your solution doesn’t have to be a radically new idea.
Does it have a substitute product that can take market share? Or, can you combine the features of multiple products during the product design process to make a combination product that patients prefer more? Could a product design consultant help answer these questions & provide knowledge transfer?
Product Development Cycle
Start by asking your cross-functional team an initial question: “What do we need to change to achieve success during the product development cycle?”. Product development strategy includes modifying existing systems & processes to accelerate efficiency. Refine your model or process based on the unique types of product solutions in your pipeline.
Product Research
Being able to understand & explain why your solution addresses a user needs statement is inherent to launch sales success. Interactive activities can be useful for improving creative conversation during market development strategy sessions. Further, voice of the customer (VOC) research consistently helps target the patient population in mind.
Finally, using VOC to identify early adopter audiences & the audience’s most important needs can increase early interest in your solution. Begin the sales process by determining core messaging ahead of the launch ramp-up based on device claims & if the regulatory submission is approved.
Market Development Strategy
User needs are the foundation of any successful market development strategy. Yet, being able to commercialize a new solution based on user needs using a team experiencing process problems is never an easy task. It requires the Engineering Team & Operations Team at the listening table earlier in the process than later.
Product Design and Development
A critical to quality objective early in the new product development process is removing everything but the essentials. Research your users needs to create design inputs for a product that patients both need & generates revenue.
Product Planning Process
After a business case is determined in the waterfall method, the product planning process begins cross functionally to validate product ideas via new product development research. What user needs will accelerate a successful product launch the fastest?
Innovative product design means addressing honest opinions from your target audience to validate your medical device solves a problem. The product development management team must be convinced the product can win in the commercial marketplace sooner rather than later.
Software Product Design
Success during the launch of a software as a medical device is often found at the heart of the product development plan. Any new product design must incorporate value added for the audience in one way, shape or form. This can include lean product design as some of the most effective software in the industry is not complicated.
Software as a Medical Device
Consider the regulatory differences between a tangible product and a technology product very carefully. For example, Software as a Medical Device (SaMD) has changed the marketplace by increasing both clinical research success & primary care delivery. Include process improvement sessions during internal meetings where a collective group deciphers what the user need statements mean to their team.
Agile Product Development
The vision for development begins with a minimum viable product, or MVP, during early software conceptualization & development; what is the business case of commercialization? How do we learn faster while making real time efficiency changes?
Digital Product Development
Product development teams must answer several questions before undertaking product design. Further, one focal ask is are successful processes already in place for medical product development.
Do you have a RACI chart to show who is responsible, accountable, considered, and informed? Finally, a clear cross-functional understanding of timelines & milestones can help guide expectations during MVP product development, which can be stressful based on the speed of common work.
MVP Agile
MVP (Minimum Viable Product) a widely accepted concept in software development in digital product development. However, our medical product design discussion will take a different direction – what is the regulatory affairs process?
A project management software development team should deliver a safe, efficacious solution with the objective of delivering patient value. Define your value through a regulatory strategy based on device claims, clinical evidence, and how both help the patient population.
Regulatory Compliance
Software as a medical device involves regulatory compliance based on multiple, widely accepted global standards.
This includes:
ISO 13485
IEC 62304
IEC 62366
ISO 14791
The product development engineering team is responsible for the software process. Any prototype development assistance should begin with a regulatory compliance perspective of claims and predicate devices.
Prototype predicate concepts begin with identifying the current risk class & why use cases help validate your proposed risk class during regulatory submission. Finally, consider younger product developers who may have never been through regulatory approval in their career. FDA readiness training can be a powerful tool that increases marketing approval & how to carefully identify and isolate risk hazards.
Regulatory Pathway
Planning the build for a product requires a regulatory pathway that includes risk management considerations based on the risk class. Create as much detail as possible during this prototyping and design inputs phase of NPD.
Product development companies, like Regulatory Compliance Associates, can help identify the correct predicate device based on a risk gap analysis. Diagrams should include material ingredients that need to be sourced to create the product. This can help you determine the risk category of the product (e.g. patient daily use, HCP specialty use, etc.) and corresponding patient hazards.
About RCA’s Medical Device Consulting Services
The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product.
Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. Our regulatory compliance solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.
For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.
At Regulatory Compliance Associates, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle. The RCA medical device consulting team understands protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval.
Regulatory affairs is Regulatory Compliance Associates® backbone. We handle more regulatory consulting submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.
As a trusted regulatory affairs consultant, our FDA veterans and regulatory consulting team represents Regulatory Compliance Associates® as one of the top medical device consulting firms. We’lll help you navigate the medical device consulting difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support.
Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.
Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.
Regulatory Compliance Associates® is globally reknown for quality assurance services, including quality system assessments, strategy, implementations, and quality metrics to ensure continuous improvement. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. RCA’s quality assurance services experts know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.
In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.
With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.
Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for our remediation services & support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.
Regulatory Action
Regulatory Compliance
Regulatory Enforcement
Warning Letter
483 Observation
Oversight Services
Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates® a competitive differentiator in the remediation space.
Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® due diligence consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.
Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.
Manufacturing Optimization
Product Lifecycle Management
Mergers & Acquisitions (M&A)
Due Diligence
Device Vigilance
Risk Management Plan
Product Complaints
Medical Information
About Regulatory Compliance Associates
Regulatory Compliance Associates® (RCA) provides medical device 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, Regulatory Compliance Associates 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
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 more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 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.
Regulatory Compliance Associates® (
Regulatory Compliance Associates® (