Regulatory Compliance Associates (RCA), a Nelson Labs company, 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.
Life Science Consulting
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. Learn More
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.
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Compounding 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. Learn More
How can we put our regulatory compliance Experts to work for you?
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White Papers
Medical Device: Clinical Evaluation Requirements
Navigating the complexities of clinical evaluations is essential for medical device manufacturers aiming to secure and maintain market access in the European Union. This white paper from Regulatory Compliance Associates®...
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Webinars
Single-use Endoscopes: Critical Safety and Regulatory Considerations for Manufacturers
The transmission of infections via endoscopy remains a critical concern due to the inherent design challenges of scopes. Single-Use endoscopes offer a pivotal solution by eliminating the risk of patient-to-patient...
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Blogs
Cytotoxicity Testing
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...
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Contact us to learn more about our regulatory compliance experts and how they can help
