Regulatory Compliance Associates®
Life Science Consulting
Regulatory Compliance Associates (RCA) is widely recognized within the healthcare industry for regulatory compliance consulting and the life science consultants who help our clients successfully resolve complex challenges. We leverage our thought leadership to advocate for our medical device, pharmaceutical, biologics, combination product, and compounding pharmacy clients.
Learn how RCA supports your industry
Medical Device Consulting
Our breadth of expertise in the Medical Device industry is globally renowned and in demand. Our services include regulatory affairs, assessments and audits, agency response, preparation and remediation, and new product development support.
Pharmaceutical Consulting
Our background and experience in the Pharmaceutical industry has helped thousands of companies meet regulatory compliance, quality assurance, and remediation challenges, in addition to supporting strategic consulting needs.
Biotech Consulting
We have the experience and insights to guide biological products through the entire lifecycle. We help companies navigate complex regulations to increase their successful launch and steer them down the complex path of regulatory compliance.
Recent News
Microbial Process Design
Click now to learn from Sue Schniepp, Distinguished Fellow at Regulatory Compliance Associates, as she describes microbial process design and how your team can improve contamination control. Human...Read More
Product Development
Click to watch Regulatory Compliance Associates medical device consultant, Dr. Stephen Coulter, discuss the common tools & processes used during product development. Early stages of new product development include analyzing...Read More
FDA Guidance: GASK
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...Read More
Medical Device Cybersecurity Guidance
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...Read More
Biocompatibility Testing
In this soundbite from RCA Radio, Dr. Helin Raagel and Dr. Matthew Jorgensen from Nelson Labs explain biocompatibility testing. This includes the risk-based biocompatibility evaluation that medical devices go through...Read More
FDA Harmonization
The FDA harmonization team has recently announced it is no longer going to be a member of the Global Harmonization Working Party (GHWP). This comes as an eye-opener for many...Read More
Medical Device Testing
In the world of medical device testing, manufacturers should seek to identify key characteristics that set a high-quality laboratory aside from the rest. A successful medical device testing relationship should...Read More
FDA Updates Supply Chain Security Guidance
The U.S. Food and Drug Administration (FDA) recently published multiple new guidance documents to help accelerate supply chain security and new product tracing requirements in the pharmaceutical industry. While most...Read More
Leveraging Outsourced Staff
In this soundbite from RCA Radio, Erika Porcelli, CEO of Regulatory Compliance Associates® (RCA), provides examples of how different size companies leverage the stage of business they’re in to...Read More
The Future of Biotech Quality
Experts share insights on what the future may hold regarding biotech quality, regulatory requirements and quality standards for biotechnology industry. The biotech industry has experienced significant growth in recent...Read More
Quality Metrics
Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates®, discusses the quality metrics journey in determining the suitability of pharmaceutical products. One of the most discussed and debated topics...Read More
QA Outsourcing
In today’s competitive business environment, life-science companies run lean, particularly in terms of personnel. The quality assurance (QA) function creates complexity for pharmaceutical companies because need and cost vary depending...Read More
Medical Device Cybersecurity
For medical device manufacturers, technology can be a double-edged sword. The technologies that elevate the quality of life for patients can be used by cybersecurity bad actors to potentially harm...Read More
FDA Inspection Procedure
Q: Companies have made a lot of operational changes to accommodate working through the pandemic. What changes do you think will become permanent in FDA inspection procedure as a result...Read More
Biotech Warning Letter
Client A combination product manufacturer received an FDA 483 warning letter for a facility that produces a branded prefilled syringe (PFS) drug delivery system with manual needle guard, vial and...Read More
Product Launch Plan
A generic pharmaceutical manufacturer was interested in applying lean principles to the operation of the Quality team, with the objective to reduce the product release timeframe. However, they lacked internal...Read More
Biotechnology Process Control
Background A Fortune 500 biotech company frequently had parts missing when assembling equipment for a campaign changeover. This led to expensive, last-minute part fabrication and concern about the potential for...Read More