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

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 the quality (QA) function in medical devices require the highest levels of expertise and leadership. The following case study illustrates...
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RCA Accelerates Product Launch While Creating Quality System

Small or emerging life science organizations often put off hiring quality executives, exposing the company to risk or worse. Other...
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RCA Designs a Shipping Validation Study for a Pharmaceutical Company with Two API Manufacturers Located in Europe

A pharmaceutical start-up with a novel drug approached RCA to design its shipping validation study. RCA developed multiple studies based...
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News

Regulatory Compliance Associates® Inc. Congratulates Susan Schniepp on her Service Appreciation Award from the Parenteral...
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News

Regulatory Compliance Associates® Inc. Congratulates Susan Schniepp on her Service Appreciation Award from the Parenteral...
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News

Regulatory Compliance Associates® Inc. Congratulates Susan Schniepp on her Service Appreciation Award from the Parenteral...
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RCA Honored with Ovation Award...
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Regulatory Compliance Associates® Inc. Advises Czech Manufacturers on U.S. Healthcare Market Compliance Procedures...
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