Category: Biologics

US FDA Consultants

Posted on by Joby Semmler

About Regulatory Compliance Associates

 

Regulatory Compliance Associates (RCA) provides US FDA consultants & consulting services to the following industries for resolution of compliance and regulatory 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. Our life science consultants 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
  • 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 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.

 

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, RCA offers leading US FDA consultants that can help you navigate through the challenges associated with evolving industry regulations.

 

Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and 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 step of the FDA consulting process. Our FDA 510k consultants will create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • 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 expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our FDA regulatory consultants span 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 FDA regulatory consulting services partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep by FDA consulting firms could mean significant and lasting consequences for client revenue and industry profitability. At Regulatory Compliance Associates, we offer the experience and FDA compliance consultants necessary to guide you in quality compliance.

 

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

 

Quality Assurance

 

Regulatory Compliance Associates® Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality life science consultants 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.

 

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

 

Remediation 

 

Regulatory Compliance Associates® has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute.

 

We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, Regulatory Compliance Associates can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

 

  • Regulatory Action
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

About RCA’s Medical Device Consulting Services

 

The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA®‘s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 life science consultants — including former FDA officials and other 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. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. We offer expertise in a variety of medical fields, such

 

Cybersecurity

 

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 we do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates, we offer a wide variety of services for medical device 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, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We 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 510k consultant experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR

 

Compliance Assurance

 

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® Inc. can help.

 

Our network of over 500 FDA, Health Canada & MHRA veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response

 

Quality Assurance

 

Regulatory Compliance Associates Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our life science consultants are quality experts 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 assistance you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry Experts are fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation

 

Remediation Support

 

Regulatory Compliance Associates is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

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 unique expertise and experience that makes partnering with RCA® a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP 

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates life science consultants can help ensure a successful mix of people and product so your project is on time, on budget, and you’re never embroiled in a costly mistake.

 

Our 500 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
  • Product Complaints
  • Medical Information

 

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. 

 

 

Interphex 2023

Posted on by Brandon Miller

Regulatory Compliance Associates® will be exhibiting at INTERPHEX in New York City from April 25th–27th 2023 with Sterigenics and Nelson Labs. Stop by booth #1753 to meet experts from each team to learn how we can provide you with a complete solution for any of your projects. Together we understand your business and are prepared to discuss solutions to your regulatory, quality, compliance, sterilization, and lab testing needs to help ensure the safety of your product and process.

interphex

Regulatory Compliance Associates® Distinguished Fellow and the Parenteral Drug Association® (PDA) Chair of Board of Directors, Susan Schniepp, will be presenting a tech talk where you will learn more about contamination control strategy, how to identify and assess risk, prepare mitigation pathways, and define 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.

About Interphex® 2023

For 40+ years, INTERPHEX has been the premier pharmaceutical, biotechnology, and medical device development and manufacturing event where you can “Experience Science through Commercialization”.

interphexBased in New York, INTERPHEX brings over 10,500 global industry professionals and 620+ suppliers together to “Learn It, Experience It, Procure It” through a unique combination of our no-cost technical conference, exhibits, demonstrations, partnering opportunities, and networking events to leverage quality, efficiency, and cost-effectiveness in today’s ever-changing global market.

 

About Regulatory Compliance Associates’ Client Solutions

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

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • 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 expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our 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 pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

Compliance Assurance

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA®, we offer the experience and resources necessary to guide you in quality compliance.

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

 

Quality Assurance

Regulatory Compliance Associates® Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts 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.

  • 21 CFR 210
  • 21 CFR 211
  • Data Integrity
  • Computerized System Validation
  • Manufacturing Support
  • Facility Support

 

Remediation 

Regulatory Compliance Associates® has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute. We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

  • Regulatory Action
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

About RCA®

Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory 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. Our life science consultants 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
  • 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 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.

 

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. 

FDA Publishes Updated Biologics Guidance

Posted on by Joby Semmler

The US Food and Drug Administration (FDA) recently issued final guidance for Biologics industry executives to help define modifications to existing products and update submission procedures.  The primary focus of the guidance is to help biologics industry employees responsible for reporting understand which type of risk category is appropriate for updated variations in chemistry, manufacturing, and controls (CMC).

 

The guidance is applicable to CMC products with an existing biologics license application (BLA) currently approved by the FDA. It’s a critical update since any Biologics company or regulatory partners must notify the FDA about every change to an approved BLA under the Code of Federal Regulations (21 CFR 601.12).

Need help adhering to the New Guidance? Contact Us Now →

FDA submission data

 

FDA Guidance

The final FDA guidance goes into detail about each post-approval change in the product, including production process, quality controls, equipment and facilities, responsible employees, and established labeling. Expanded submission data will potentially provide greater detail about the the risk profile related to the changes, and how revised changes impact the intended safety or efficacy of the product.

 

Assessing and implementing manufacturing changes is laid out in great detail in the FDA guidance. Comparability data will be used to show variations of the product pre- and post- changes. The comparability analysis is necessary to help gauge possible effects of the product changes. Data from the analysis will be represented through a variety of sources, including a combination of testing, validation studies, and non-clinical or clinical studies.

 

FDA submission procedure

 

More importantly, the guidance provides a greater amount of detail about the updated FDA submission procedure. A significant focus of the guidance acknowledges the opportunity for adverse effects and how to measure and minimize based on data about the revised formulation. The biologic submission must show reference information that considers the new identity, strength of the product, quality of the product, and purity or potency of the product.

 

The three unique types of Biologics reporting includes Prior Approval Supplement, Changes Being Effected in 30 Days/Changes Being Effected (CBE30/CBE) and an Annual Report:

 

Prior Approval Support (PAS)

  • This includes changes that have significant potential for an adverse effect on product quality. The PAS must be approved by the FDA before a Biologics company can distribute any updated BLA approved product to the market involving the changes.

 

Guidance Changes Being Effected in 30 Days/Changes Being Effected (CBE30/CBE)

  • This includes changes that have a moderate potential to have an adverse effect on product quality. The CBE30/CBE requires an applicant to report the change to the FDA in a supplement at least 30 days before distribution of the product to the market.

 

Annual Report (AR)

  • This includes changes that have a minimal potential to have an adverse effect on product quality.

 

FDA process validation

 

Assessing the impact of the change on product quality is critically important in the reporting submission.  Reporting data should include prior knowledge and findings from product development activity. Documentation surrounding process validation activities and manufacturing expertise of the approved BLA product are also requested.

 

Quality risk management activities or pre-commercial studies that provide expanded awareness of the effects of the changes can also be very valuable for FDA decision makers. Finally, a cumulative impact assessment of multiple changes on the updated BLA product can help ensure post-market surveillance activities are aligned between the FDA and Biologics company.

 

Quality Management System

 

References to a robust quality culture appear throughout the guidance, including developing of robust manufacturing processes and process controls. Innovative process validation techniques and analytical testing are listed as critical drivers Biologics companies should practice to help mitigate risks associated with manufacturing changes.

 

Having an effective quality risk management system allows Biologics industry executives to make knowledgeable choices regarding manufacturing variations. The quality system data increases the confidence of product quality and process consistency for both executives and the FDA. Formal and informal risk assessments to support of post-approval manufacturing changes increases the accuracy of a more effective assessment of the change, which can increase the speed of the FDA’s decision.

 

About RCA’s Biologics & Biotech Consulting Services

Regulatory Compliance Associates® can assist you in ensuring the quality of your biologics or biosimilar product during its entire lifecycle. From pre-market to post-market reviews, inspection, and compliance, our Biotech consulting experts can shepherd your biologics through design, labeling, promotion, production, and testing. Our Biologics consultants & consulting services include:

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates®  backbone and we fully understand the complexities of the biologics industry. Our biotech consulting expertise spans all facets and levels of Regulatory Affairs, from early phase & bioanalytical sciences through late phase and post approval.

 

  • Preclinical & CMC Consulting
    • FDA Meetings & Briefing Package Assistance
    • Clinical Trial Applications
    • Marketing Applications
    • Medical Writing
  • Lifecycle Management
  • Submission Planning & Strategic Support
    • eCTD Publishing & Submissions
  • Strategic Consulting & Intelligence
  • US Agent
  • Project Management Support
  • Clinical Development Support
    • Clinical Research Organization (CRO) Sourcing
  • Analytical Development Support
    • Bioassay Design & Validation
    • Immunoassay Support
    • Statistical Analysis & Specification Setting

 

Compliance Assurance

 

Biotech ConsultingIncreasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s biologics consultants preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® biotech consulting global team can help.

 

  • Assessments
    • Current Good Manufacturing Practice (cGMP)
    • Corrective & Preventive Action (CAPA), Investigations & Deviations
    • Facility & Maintenance 
    • Data Integrity
    • Quality System Gap Assessment
  • Audits
    • Supplier Audits
    • CRO Audits
    • cGMP Compliance Audits: Manufacturing, Pilot Plant, Laboratory
    • cGLP Audits
    • Good Clinical Practices
  • Preparation, Training & Inspection Readiness
    • cGMP Fundamentals (Annual Training Required by Regulations)
    • Quality System Regulation
    • Risk Management
    • Investigations, Deviations & CAPA & Root Cause Analysis
    • Validation & Technology Transfer
    • Purchasing Controls & Supplier Management
    • Document Management & Change Control
    • Audit Readiness
    • Quality Culture & Management Responsibility
    • Data Integrity & Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error

 

Quality Assurance

 

Regulatory Compliance Associates® Quality consulting services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics. Our biologics consultants goal is to ensure continuous improvement, aligning with your business needs and goals. Our biotech consulting subject matter experts have 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.

 

  • Quality Management System Implementation
  • SOP Development
  • Document Control Systems
  • Change Control
  • Laboratory Operations & Control

 

Remediation Strategy & Response

 

Regulatory Compliance Associates® is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, Regulatory Compliance Associates® biologics consultants have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

  • Regulatory Action
    • 483 Response & Remediation
    • Warning Letter Response & Remediation
    • Consent Decree Response & Remediation
    • Oversight Services
  • Consulting
    • Comprehensive Audits
    • Remediation Plan Development & Implementation
  • Manufacturing Support
    • Re-validation of Existing Equipment & Processes
    • Remediation of System Deficiencies Related to, Manufacturing Process, Equipment, or Facility 
    • Facility Improvements (Aging Facilities) 

 

Strategic Consulting

 

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

 

  • Portfolio Management
  • Mergers & Acquisitions / Due Diligence
  • Staffing Support

 

About RCA

 

Regulatory Compliance Associates® (RCA) provides biologics consulting & biotech 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 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.

 

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. 

Challenges with Transitioning to the EU In-Vitro Diagnostic Devices Regulation (EU-IVDR)

Posted on by Brandon Miller

The application date of May 26, 2022, for the EU In-Vitro Diagnostic Medical Devices Regulation (2017/746) (IVDR) has created a huge challenge for IVD medical device firms planning to introduce or continue to market their IVD products to any of the European Union Member States. 

 

One of the biggest changes from IVDD to IVDR is the move from list-based IVD device classifications to a rule-based IVD medical device classification resulting in 4 new device classes: class A (lowest risk) to class D (highest risk), where class B, C, and D would require Notified Body involvement.

Need help with your transition to the EU IVDR? Contact Us Now →

Photo of Seyed Khorashahi
Seyed Khorashahi, Executive Vice President of Medical Device and CTO

“The combination of major changes to the IVDR device classification resulting in 3-fold increase in IVD medical devices requiring notified body involvement and lack of adequate IVDR designated notified bodies has created a huge bottle neck to getting ready for the EU IVDR by the application date of the EU IVDR.” says Seyed Khorashahi, Executive Vice President of Medical Device and CTO of Regulatory Compliance Associates Inc.® (“RCA”).

 

This change alone would result in a huge number of medical devices requiring Notified Body involvement. It is estimated this quantity of medical device products will increase from 20% under MDD to approximately 80% under IVDR.  As of this writing, there are only 4 IVDR designated Notified Bodies, which visibly increases the number of goods our clients must submit. 

 

Photo of Lisa Michels
Lisa Michels, General Counsel

 “Right now, we’re partnering with global clients that have both a small and sizable product portfolio of In-Vitro Diagnostic Devices, and they are at different stages in their IVDR implementation efforts,” says Lisa Michels, General Counsel for Regulatory Compliance Associates® Inc. (RCA). “Proactive strategic planning and effective resource allocation are critical for the timely execution and implementation of a comprehensive IVDR Implementation Plan. IVDR manufacturers must consider and prepare for potential delays such as scheduling bottlenecks for Notified Body Conformity Assessment activities, which may directly or indirectly impact their planned commercialization efforts for existing and/or new IVDR products. It is necessary for IVDR manufacturers to establish contingency plans to mitigate some of these potential challenges in this new regulatory environment under the EU IVDR since all IVDR manufacturers are facing the same task.”

 

Additional nuances from IVDD to IVDR are based on a medical device lifecycle approach and include:

 

 

The transition from IVDD to IVDR can be a time-consuming process, and many companies are still in the process of regulatory transition. 

 

“It’s time-sensitive because our clients are learning how to deal with their current notified body, and if they are still the correct partner to work with” continued Khorashahi. “We initially start with a strategic approach to plan their regulatory strategy of current IVD medical devices in the field and their IVDD certificate expiration date to prioritize the products that need immediate attention. “Each of the IVD medical devices has to be reclassified according to the new IVDR device classification rules.”

 

If you are a small to medium size company and have not already started your transition, now may be the opportune time to engage with a strategic partner like RCA to prepare for the IVDR deadline.

 

“Timely compliance to the IVDR requires a dedicated team of subject matter experts to properly implement and execute the compliance deliverables as laid out in your IVDR Implementation Plan” continued Michels. “These deliverables may require extensive updates to a manufacturer’s existing Quality Management System (QMS), technical documentation, and/or establishing or enhancing a manufacturer’s body of objective evidence of clinical performance validation with a defined blueprint to address the product lifecycle.”

 

IVDR

Your organization has a better chance of a successful transition by engaging subject matter experts like RCA who have an intimate familiarity with the planning and implementation of IVDR.

 

“Our experts can help you identify the intended purpose and the inherent risks associate with your devices, determine the device classification, and help create technical documentation in compliance with IVD regulation 2017/746.:es” Khorashahi divulges.

 

More robust procedures for post-market surveillance and post-market performance follow up must be put in place to successfully transition.

 

“RCA has the subject matter expertise, experience, and dedicated resources available to assist our clients with the seemingly daunting task of ensuring timely IVDR compliance prior to the fast-approaching deadline. Our proven capability is what clients find to be of most value in the selection and utilization of a regulatory compliance consulting firm like RCA.” replied Michels.

 

About RCA

Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory 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-and globally-regulated companies.

 

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

 

 

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. 

Best Practices for FDA Remote Inspections

Posted on by Brandon Miller

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 remote inspections in place 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.

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How Would a Virtual Inspection Work?

Virtual health authority inspection is accelerating as the Pandemic continues. FDA registrations simply don’t end and some health authorities outside the US have already done remote inspections already (e.g. the EMA). However, while the FDA has not done a true remote inspection, they have done many hybrid inspections.

 

What does the hybrid approach mean?

 

It is part of onsite work and part offsite/remote work. With the hybrid FDA format, the FDA uses tools like video chat for activities like virtual interviews. 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 in an inspection.

 

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 virtual inspection

 

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 Virtual 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).

 

About RCA

 

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.

Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and 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, RCA® Inc. will guide you through every step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • 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 expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our 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 pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

Compliance Assurance

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA® Inc., we offer the experience and resources necessary to guide you in quality compliance.

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

 

Quality Assurance

Regulatory Compliance Associates® Inc.’s Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts 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.

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

 

Remediation 

Regulatory Compliance Associates® Inc. has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute. We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

  • Regulatory Action
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

About RCA®

 

Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory 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. Our life science consultants 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
  • 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 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.

 

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. 

 

 

Inshoring Strategy

Posted on by Brandon Miller

As with many industries these days, pharmaceutical manufacturers are now reevaluating the structure of their manufacturing operations. A specific focus area is whether returning some or all production processes to American shores (inshoring) is a more practical and cost-effective alternative to the offshoring trend that’s been prevalent for several decades. 

 

Are you Considering In-Shoring your Pharmaceuticals?  Talk to our Experts →

 

Factors That Impact the Inshoring/Off-Shoring Decision

Examples of crucial considerations when in-shoring pharma include:

 

Manufacturing

If yours is like many pharma operations, you chose to outsource due to the lower production and labor costs available overseas. If it’s been a while since you’ve compared manufacturing abroad vs. at home, consider conducting a comprehensive cost analysis. You might be surprised to learn that you can now produce a pharma product in the U.S. more cheaply than before. In some cases, the costs are now nearly as low as in China.

 

Suppose your manufacturing cost analysis yields favorable results and you determine to move forward with in-shoring. The next step is to decide the type of manufacturing facility that makes the most sense for your operation. Specifically, you should determine whether a brownfield (existing) or greenfield (brand-new) site is the better option. 

 

Technology

If you’re evaluating an existing structure, take a look at the current equipment and technology. Are they compatible with your projects’ demands? If not, can you make cost-effective upgrades or modifications to bring them up to speed? If these hurdles are prohibitive, building a greenfield facility will likely provide a more practical and affordable long-term solution. 

 

A greenfield site enables you to customize your manufacturing processes more effectively since you are building and equipping the facility from scratch. On the downside, the costs of a new building, compatible machinery, and hiring and training fresh personnel may not be affordable for some pharma operations. And constructing a new facility from the ground up takes time — a commodity that’s often in short supply in today’s ultra-competitive pharma industry. 

 

Supply Chain

Supply chain access is another vital factor when in-shoring pharma operations. Given that many of the raw materials and ingredients used to manufacture pharma products and medical devices come from outside the U.S., finding acceptable substitutes at home can pose a challenge. If you must import them, you’ll need to consider the added transportation and costs of these components.

 

You’ll also need to account for all applicable supply chain qualifications. For instance, if you’re partnering with new suppliers, you must ensure they meet your company’s unique qualification and quality criteria. Transportation concerns are another issue to evaluate. Will you be able to get the materials to your facility reliably on time to accommodate your production schedules? You’ll need to implement a qualified transportation system for certain essential ingredients and finished goods. 

 

Operations

From a business/operational perspective, consider how in-shoring pharma will impact your personnel. For instance, if you decide to move into an existing facility, determine if there will be sufficient space for your workers and any new equipment you add. Also, can the facility accommodate essential areas such as clean rooms, warehousing, waste treatment systems, and cold storage spaces?

 

If you’re relying on outdated technology systems, you’ll likely need to make upgrades to meet the changes in demand. Examples of systems that require careful evaluation include ERP, CAPA management, and eDoc, to name a few. 

 

About RCA

Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory 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-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

 

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. 

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