Regulatory Compliance Associates® (RCA) is widely recognized within the healthcare industry and life science consultants 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. We leverage thought leadership networks to advocate for our medical device, pharmaceutical, biologics, combination product, and compounding pharmacy clients.
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. Our life science consultants 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
- Eastern Europe
- Regional offices
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
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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.
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.