Regulatory Compliance Associates® (RCA) Life Science Consulting
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:
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
- Regional offices
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021

Medical Device Consultants
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.
Recent News
IME South 2022
FDA ISO13485 Update
CPhI North America 2022
Interphex 2022
Parenteral Products Sterilization and Extractables Evaluation to Help Ensure Drug Safety
FDA Guidance for Clinical Trials
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