The pharmaceutical and biologics industry recently received updated FDA guidance on the use of Generally Accepted Scientific Knowledge (GASK) in regulatory submissions.
The FDA guidance provides new examples of when it is applicable to leverage GASK data to meet safety requirements required in a new drug application. Clinical information in the drug discovery data that supports the nonclinical safety of a drug can contain GASK citations. Additionally, the citations would be based on existing clinical studies that have been validated by FDA in approved products on the market.
What is GASK?
Generally Accepted Scientific Knowledge refers to information and methods widely considered as accepted by life science industry experts. It can include established scientific principles, published papers, and best practices that have passed the regulatory scrutiny of drug development. GASK is most often utilized during the evaluation of safety and efficacy data of regulated products.
FDA Approval
The FDA guidance elaborates on the process of FDA regulators and how new drug applications are evaluated. Further, the FDA often requires life science companies to provide a significant amount of regulatory data to support safety and efficacy claims.
This regulatory clinical research often comes from clinical trials, preclinical studies, and other types of scientific data sources. However, in scenarios where there may be limited clinical trial data conducted, GASK can be used to provide supporting documentation for regulatory compliance.
Drug Development
Life science companies are required to offer nonclinical information to support regulatory approval of a New Drug Application (NDA) or Biologics License Application (BLA). Additionally, the FDA guidance elaborates on how nonclinical information helps the Agency focus on important matters, such as:
Identifying pharmacological effects, including the mechanism of action of the drug in vitro and/or in vivo
Identifying absorption, distribution, metabolism, and excretion of the drug in vitro and/or in animals
Identifying possible consequences of exposure duration (e.g., chronic)
Identifying risks for special populations (e.g., pediatrics)
Regulation Examples
The FDA guidance goes on to describe unique conditions in which sponsors have successfully used GASK in their product development program. Each sponsor cited these GASK resources to meet FDA’s regulatory approval requirements instead of conducting certain nonclinical studies:
Products containing a substance that naturally occurs in the body. Sponsors submitted GASK regarding that substance and the known effects on biological processes.
Demonstrated drug impact on a particular biological pathway. Sponsors submitted GASK regarding the impact and FDA regulators concluded specific nonclinical studies were not necessary to support drug approval and drug labeling.
Active Ingredient
The FDA guidance continues by listing examples of substances that are typically present in a healthy human body. For example, endogenous substances where the drug replaces a substance that should naturally be present but, for pathological reasons, a patient may lack sufficient amounts. The FDA approved drug may enable and help accelerate the proper functioning of the human body.
Pharmacological
Additionally, a key driver of using GASK for FDA approval is the patient who has been prescribed a drug & the pharmacological impact experienced. Existing human pharmacokinetic studies and toxicology studies are recommended and may support the approval of the regulatory application. Specifically, regulators wil look to examine if the drug helps increase the level of the endogenous substance to the level of a healthy individual.
Diet
Further, exogenous substances that are already present in a patient’s diet may help expedite U.S. Food and Drug Administration approval. This scenario includes a patient’s exposure to an unmodified food substance that doesn’t exceed typical levels of dietary exposure when the drug is taken orally. The FDA guidance also states that certain nonclinical studies may be unnecessary based on the relevance of the exogenous substance to the clinical research submitted.
New Drug Application
If an FDA sponsor utilizes GASK information in their new product application, they must submit justification in the appropriate regulatory submission filing (e.g. BLA submission, 510(k) submission, etc.). The FDA guidance recommends as early as possible in product development to the assigned FDA regulator.
Finally, food and drug regulation feedback would be provided to the sponsor for the proposed regulatory strategy for approval. The FDA submission should incorporate evidence for the use of GASK, including textbook excerpts and/or non-product-specific published literature.
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].
In this soundbite from RCA Radio, Dr. Helin Raagel and Dr. Matthew Jorgensen from Nelson Labs explain why the Cytotoxicity test during a biocompatibility evaluation is the most important test you will run.
What is Cytotoxicity? – Cytotoxicity is the degree to which a substance can cause damage to a cell. A substance or process that causes cell damage or death is referred to as cytotoxic, “cyto” meaning cell and “toxic” meaning poison. (Will the device kill or harm the cells it comes in contact with?)
There are three reasons why the cytotoxicity test is the most important test you run during a biocompatibility evaluation.
The test can be run quickly.
It is the most cost-effective test in an evaluation.
Most evaluation concerns come from the cytotoxicity results.
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 compliance enforcement 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, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.
Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more 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 industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the 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® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We 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® medical device strategy 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.
Click now to listen to RCA’s Susan Schniepp and Steven Lynn, in this RCA Radio audio update:
Personalized Medicine
Software as medical device (SaMD) continues to emerge in consumer products, including diabetes and sleep management. When it comes to FDA cybersecurity, every device developer knows the ecosystem is more likely to be wifi-connected than ever before. Cyber awareness involves using design controls to consider a variety of consumer SaMD applications & how they connect to smartphone operating systems and open network solutions. By scaling efficacy technology, or personalized medicine, developers are addressing a rapidly growing segment of healthcare treatment.
FDA Cybersecurity
How can regulatory compliance help protect consumers from hackers when forwarding patient info between sources is involved? During a risk assessment, a SaMD consultant might end up looking at every step between the health system provider and convenience of not visiting a clinical environment. Further, as industry leaders who understand how technology can increase the speed of personalized medicine to market, what types of cyber awareness becomes more critical to protecting patients?
Home Dialysis
One SaMD cybersecurity focus Schniepp has already identified is in the Home Dialysis industry. Medical device manufacturers are continuing to evolve with the demand for smaller prototype devices in general, which may enhance cyber convenience becoming a competitive advantage. However, the commercial cyber threat is permanent and even the largest organizations in the dialysis industry can be a target.
Combination Products
Lynn agrees & understands that an FDA combination product strategy will continue innovation by means of software and drug delivery. This fundamental mindset change requires extending the definition of “users” of these connected medical devices. It includes patients and HCPs — but also FDA inspection roles needed during during regulatory compliance (e.g. biomedical engineers, IT engineers).
Fixed Dose Combination
Any combination device would include cyber awareness practices between medical devices & connected facilities that demonstrate and prove trust. Do the relationships between healthcare infrastructure increase or decrease exposure to disruption? Further, where could any attack surface breach trust and cause harm to the patent (e.g. disrupting a patient dosing device). Cyber awareness understands that intended use of the device must also address the perspective of an unwanted attacker.
Regulatory Compliance
Lynn & Schniepp both agree on one topic: patient compliance. Any type of medical device software that increases patient adherence during a healthcare routine will be applauded by FDA consultants. FDA SaMD guidance lists the ISO standards and QMS regulations needed for the submission. Accelerating the intended use through increased compliance is a regulatory strategy that can be presented via clinical evidence.
About Susan Schniepp
Regulatory Compliance Associates® Distinguished Fellow and the Parenteral Drug Association® (PDA) Chair of Board of Directors, Susan Schniepp, will be presenting a tech talk at INTERPHEX® in April 2023 where you can learn about contamination control strategy, how to identify and assess risk, prepare mitigation pathways, and defining preventive actions associated with contamination in sterile product manufacturing.
Sue is the knowledge leader for RCA® and is Chair of the Parenteral Drug Association (PDA) Board of Directors. Sue’s background includes cGMPs, audit readiness, change control, investigations, supplier quality, and batch record review.
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 compliance enforcement 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, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.
Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more 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 industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the 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® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We 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 of 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® medical device strategy 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.
The International Medical Device Regulation Forum (IMDRF) recently published updated cybersecurity guidance for the medical device industry. The medical device cybersecurity working groups at IMDRF have been busy lately, publishing multiple final documents about medical devices & software as medical device (SaMD).
Regulatory Compliance
IMDRF’s medical device guidance provides steering assumptions for both regulatory compliance & medical device cybersecurity, which are appropriate for sponsors developing medical devices. Further, a primary objective of the guidance is simultaneously increasing patient safety & reducing external threats for providers and HCPs.
Global Harmonization
The guidance begins with harmonization concepts that could affect multiple departments inside a medical device manufacturer. Additionally, key areas for harmonization programs highlighted by the cybersecurity guidance include:
Product design
Risk management activities
Device labelling
Regulatory submission
Information sharing
Post-market activities
Product Life Cycle (PLC)
IMDRF’s cybersecurity guidance continues on with a deeper evaluation of risks associated across the product life cycle. It is recommended for potential vulnerabilities to be considered for any product life cycle stage, especially considering legacy devices that may be vulnerable to strategic risk.
Product Design
Product design considerations include the initial phases of medical device development and continues until the end of support (EOS) once a product is discontinued. The four product design stages the cybersecurity guidance refers to when it comes to total product life cycle:
Development Stage
Support Stage
Limited Stage
End of Support
Development Stage (Stage 1)
The Development Stage occurs during the pre-commercialization phase before a medical device is approved by a regulatory body. This is when medical device manufacturers begin to incorporate security into the product concepts being designed. Design controls are critical in this stage for medical device manufacturers to leverage when considering how to mitigate risks.
Finally, an important deliverable of the Development Stage is product-related security documentation. The documentation is designed to help unfamiliar users to understand how to securely operate the medical device.
Support Stage (Stage 2)
The Support stage is during the initial post-launch phase and may continue for many years. Medical devices in this stage are:
Currently used for providing patient care
Available for purchase on the open market
Contain major software, firmware, or programmable hardware components
Support for software, firmware or components is provided by the medical device manufacturer
Additionally, medical devices in the Support stage should receive full cybersecurity support. This support often includes software patches, software updates, hardware updates, and incremental support the manufacturer considers appropriate.
Limited Support Stage (Stage 3)
Medical device manufacturers continue to provide cybersecurity support during Stage 3. However, as product development transitions to a more current medical device design, different constraints are involved with the transition. Medical devices in Stage 3 often require additional network controls compared to medical devices in Stage 2:
Third-party components or software may be used more frequently than internally developed updates or patches
Cybersecurity best practices integration is often governed by the ease of following support practices outlined in the Stage 2
Medical device manufacturers must explain to users the existing limitations that are now recognized in the devices and services affected
Healthcare providers using the medical device should begin to take more of an active role in unmitigated features of security defense.
End of Support Stage (Stage 4)
Medical devices in Stage 4 are considered more vulnerable than any of the other stages. They may still be in use for providing patient care, but they have been publicly identified as no longer being supported by the medical device manufacturer. Each of these scenarios result in a medical device that cannot be consistently defended against modern cybersecurity dangers.
Critical facets healthcare information technology departments should look for include:
Medical devices that have been declared EOS by the medical device manufacturer
Medical devices that are not actively marketed or sold by the medical device manufacturer
Medical devices that contain software, firmware, or programmable hardware components no longer supported by software developers
Medical devices with known risks to device safety and effectiveness that are unmitigated
Risk Management
Further, the guidance calls for a risk management approach to product lifecycle management featuring:
Security risk analysis
Security risk evaluation
Security risk control
Security risk acceptability
The cybersecurity guidance expands on product design and how security is incorporated and maintained through the product life cycle. This can be accomplished through using risk control and a secure development framework.
Risk mitigation recommendations for medical device manufacturers include:
Security design and controls based on intended use of the medical device
Security risk assessments across the risk management process
Threat modelling to help determine operational risk
Security testing and communication for medical device manufacturers include:
Customer facing product security documentation & communication
Post-market monitoring of cybersecurity vulnerabilities
Identification of vulnerabilities in third party risk management
Vulnerability risk identification based on the device security design, controls, and mitigations
Ensuring availability of security patches & mitigations based on device risk:
Coordinated and clear communication to all affected users
Description related to the vulnerability and its corresponding mitigations
Identification of other mitigation options when a security patch is unavailable
Data Integrity
One of the core principles the guidance stresses is cybersecurity information, data integrity and the importance of information sharing. IMDRF encourages medical device industry stakeholders to implement a proactive pre- and post-market approach to cybersecurity information sharing.
Moreover, timely information can help the industry recognize threats, evaluate associated risks, and react quickly as needed. An increase in industry transparency could directly benefit healthcare providers, medical device users and medical device companies.
Security Updates
An important section of the medical device cybersecurity guidance details stakeholder responsibilities related communications, risk management, and transfer of responsibility. Specifically, it is important that medical device manufacturer communications are comprehensive & identify types of documentation needed and when the medical device user may need it.
Product Security Documentation
Medical device manufacturers should ideally provide PLC documentation about security or support changes early in the Support stage. This helps HCP risk management during both the procurement & deployment of medical devices. Types of life cycle support for product security documentation includes:
Manufacturer disclosure statement for medical device security
Software Bill of Materials (SBOM)
Security test report summaries
Third-party security certifications
Customer security documentation
Product Life Cycle Documentation
Medical device companies should communicate the strategic life cycle milestones to their customers. Further, these interactions would include cybersecurity EOL and EOS dates if available. This helps to support HCPs during both the procurement & installation process.
Additionally, medical device manufacturers should provide this information as far in advance as possible. The goal is at least 2 years in advance to best support healthcare professionals with the following information:
Affected medical devices
Medical device operating system(s)
Version of medical device deployed
Medical device software components
Expected date of medical device service changes
Extent of medical device maintenance after a service change occurs
Additional design controls that help all involves parties
Vulnerability & Patching Information
If a vulnerability is uncovered, medical device companies should provide related vulnerability information. Further, the guidance specifically mentions the importance of both the appropriate mitigation or available software patch. Additionally, the guidance stresses an elevated priority be placed on high-risk vulnerabilities where timely communication is required. This communication is designed to help prevent both patient injury or device interruption.
Finally, the mitigation method and implementation instructions should be provided to the medical device operators. These security updates include both an over-air update or deployment of service personnel to help install the remedy.
Proactive Communications for Third-Party Components
Medical device software and other digital components within a medical device will reach EOL/EOS before the product itself does. In these cases, risk can increase based on the lack of support for these elements. To help compensate for these security risks, the cybersecurity guidance suggests medical device companies should:
Validate the list of third-party components used in medical devices
Track support status updates of third-party components used within their device
Assess the risks that exist when third-party components become unsupported
Communicate new risks and available risk mitigations to healthcare providers
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].
The onset of a global pandemic and other factors are causing many U.S.-based pharmaceutical and medical device companies to evaluate whether to bring back manufacturing facility operations they’ve previously outsourced to other countries. In a time where ensuring quality is paramount, insourcing has the potential to allow these organizations to implement more stringent quality control standards. Deciding between a brownfield and greenfield strategy also optimizes logistics networks and reduces transportation costs, provided raw material suppliers are readily available.
A primary consideration when onshoring manufacturing is deciding whether to select a brownfield or greenfield site.
What Is a Brownfield Facility?
A brownfield manufacturing process utilizes a suitable existing facility and infrastructure. In many cases, the manufacturer will either purchase or lease the structure and perform any modifications required to complete the “fit-out”. In many brownfield projects, production is already occurring and personnel who are familiar with the projects and compatible quality control systems are in place. This may even be an existing facility within the corporate structure of the company.
The most obvious advantage of choosing a brownfield site is a faster implementation. There’s no need to wait for the construction of a new facility, which could take a year or longer. If executed correctly, the transition to a brownfield facility can be quick and seamless, reducing downtime and minimizing disruptions that negatively impact service. Additionally, these sites may have legacy tech systems (ERP, eDoc, CAPA etc.) that can integrate the new operational processes.
On the downside, brownfield facilities may have some production limitations due to the nature of the existing infrastructure. Scaling the operation may also pose significant challenges. As these structures are often older, they may have some operational inefficiencies and require more maintenance and upkeep. Some systems may even require replacement or considerable overhaul.
If you’re exploring the possibility of moving into a brownfield site when onshoring manufacturing processes, it’s essential to evaluate its current validation status. Transferring a new product into an existing facility often triggers a regulatory inspection and could lead to inspectional observations surrounding existing operations.
What Is a Greenfield Facility?
A greenfield site entails the construction of a manufacturing facility from the ground up. The manufacturer has more flexibility to customize the structure’s design to the project’s unique requirements. With proper planning, the site can also accommodate future growth more efficiently. Maintenance costs are usually lower than with a brownfield facility, as the building, equipment and machinery are typically brand-new and in peak operating condition.
One drawback to opening a greenfield site is time. It may not be a viable option if the manufacturer must act quickly to keep up with customer demand or bring a new product to market when there is an immediate need. Hiring new staff and onboarding can also introduce a significant learning curve and lengthen the time frame until operations are up to speed.
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. Our pharmaceutical consulting Experts will create a customized approach depending on your product and 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. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, 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. Finally, our regulatory compliance services team excels in transferring continuous improvement 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, 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 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.
Why has product launch become more complex after the pandemic & how have the “roots of compliance” changed the EU regulatory environment?
In this sound bite from RCA Radio, host Brandon Miller is joined by Kinga Demetriou, an Expert Certifier at BSI, as they discuss how the pandemic changed the “roots of compliance” in the EU regulatory environment.
Since the pandemic, quick routes to market such as EUAs have been stopped leading to market servaliance company’s putting more scrutiny on products (e.g. PPE masks)
Manufactures have found out that offering a products in different markets take a lot of recourses to understand the roots of compliance depending on the location
Different market access requirement have been introduced depending on geography
New rules and certifications are in place making it more complex to launching products in multiple markets
Listen to the full Podcast on Global Regulatory Trends –> Click Here
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].
The pharmaceutical and biologics industry recently received updated FDA guidance on the use of Generally Accepted Scientific Knowledge (GASK) in regulatory submissions.
Regulatory Compliance Associates® (
Regulatory Compliance Associates® (