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

Mission Statement

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.