Regulatory Compliance Associates®
Life Science Consulting
Regulatory Compliance Associates (RCA) is widely recognized within the healthcare industry for regulatory compliance consulting and the life science consultants who help our clients successfully resolve complex challenges.
By mining regulatory intelligence, our pharmaceutical consultants & medical device consultants continuously evaluate the global regulatory compliance audience. We leverage thought leadership networks to advocate for our medical device, pharmaceutical, biologics, combination product, and compounding pharmacy clients.
About Regulatory Compliance Associates
Regulatory Compliance Associates (RCA) provides regulatory compliance consulting to the following industries:
- Life Sciences
- 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. Our life science consultants are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.
As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,000+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.
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Medical Device Consulting
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 new product development support.
Pharmaceutical Consulting
Our background and experience in the Pharmaceutical industry has helped thousands of companies meet regulatory compliance, quality assurance, and remediation challenges, in addition to supporting strategic consulting needs.
Biotech Consulting
We have the experience and insights to guide biological products through the entire lifecycle. We help companies navigate complex regulations to increase their successful launch and steer them down the complex path of regulatory compliance.