Regulatory Compliance Associates® Inc. is Your Go-To Source When the FDA Calls

We’re widely recognized within the life science industry and global regulatory agencies for our ability to help companies successfully resolve complex regulatory challenges. By mining regulatory intelligence, we continuously evaluate the FDA’s current thinking and leverage thought leadership networks to advocate for our medical device, pharmaceutical, biologics, combination product, and compounding pharmacy clients.

Medical Device

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 strategic consulting on new product development, lifecycles, and staffing support.

Pharmaceutical

Our background and experience in the Pharmaceutical industry has helped thousands of companies meet regulatory, compliance, quality assurance, and remediation challenges, in addition to their strategic consulting needs.

Additional Services

We have the experience and insights to guide biologic products through the entire lifecycle. We help companies navigate complex regulations for Combination Products to increase their successful launch and steer Compounding Pharmacies down the complicated path of compliance.

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Case Studies

Biosimilar Drug Development

Client Challenge A European based company engaged in biosimilar drug development requested RCA to develop a regulatory strategy, whereby they could seek approval for their drug in the US and EU. A major challenge was that the client wanted to...
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Design and Build Out of Biologics Facility

Client Challenge A European based company engaged in biological drug development was involved in an enormous undertaking when they contacted...
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RCA’s Outsourced QA Leadership Benefits Emerging Device Maker

In today’s competitive business environment, emerging life science companies run lean, particularly in terms of personnel. However, the complexities of...
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News

Susan Schniepp Makes Impression With Talk About Quality Culture in Berlin...
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News

Susan Schniepp Makes Impression With Talk About Quality Culture in Berlin...
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News

Susan Schniepp Makes Impression With Talk About Quality Culture in Berlin...
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Insights on Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production...
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PDA Midwest Chapter – Regulatory Submissions & Changes...
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