Regulatory Compliance Associates® (RCA) is 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, our pharmaceutical consultants & medical device consultants continuously evaluate the global regulatory audience and leverage thought leadership networks to advocate for our medical device, pharmaceutical, biologics, combination product, and compounding pharmacy clients.

About RCA

Regulatory Compliance Associates^® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

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.

• Founded in 2000
• Headquartered in Wisconsin (USA)
  • Regional offices
    • Florida
    • Colorado
    • Eastern Europe
• Expertise backed by over 500 industry subject matter experts
• Acquired by Sotera Health in 2021