We Understand the Complexities of Running a Life Science Business
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device 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 with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Southeastern Wisconsin, with offices in West Central Florida; North Central Colorado; and Central Eastern Europe
- Expertise backed by over 500 industry subject matter experts
Regulatory Compliance Associates® Inc. is driven to improve the overall health and well-being of patients around the world by providing expert consulting services tailored to the business needs of its clients.
The RCA Global Difference
- We are the consultants who know how to get things done with quality results, on time and on budget.
- Our expert resources are a strategic blend of top industry veterans, experienced specialists, and stellar consultants to support any project need.
- Our management leaders each have two to three decades in FDA-regulated industries.
We have walked the walk.
- Our approach is differentiated to meet your specific needs.
- We can provide excellent references, case studies, and testimonials.
- Our strategy to execution is priced appropriately.
Why Choose RCA
- RCA is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges.
- By mining regulatory intelligence, RCA continuously evaluates FDA’s current thinking and leverages thought leadership networks to advocate for our clients.
- We know a quality or compliance crisis can significantly impact your business. We have the experience to manage them.
- We have the know-how and proven approach to navigate warning letters, consent decrees, and other situations.
- We know how to partner with your executive, legal, and communication teams.
- We support management to assist with the growing and changing concerns.
- We help navigate the storm and manage the impact to your business.
Commitment to Quality
Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.
"You won't find a more talented team, a more personable group, or one more dedicated to your success than Regulatory Compliance Associates."
—Senior Manager of Corporate Reliability Engineering