Regulatory Compliance Associates® Inc. is Your Go-To Source When the FDA Calls
We’re 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, we continuously evaluate the FDA’s current thinking and leverage thought leadership networks to advocate for our medical device, pharmaceutical, biologics, combination product, and compounding pharmacy clients.
Medical Device
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.
Case Studies
Biosimilar Drug Development
Client Challenge A European based company engaged in biosimilar drug development requested RCA to develop a regulatory strategy, whereby they could seek approval for their drug in the US and EU. A major challenge was that the client wanted to...Read More
Design and Build Out of Biologics Facility
Client Challenge A European based company engaged in biological drug development was involved in an enormous undertaking when they contacted...Read More
RCA’s Outsourced QA Leadership Benefits Emerging Device Maker
In today’s competitive business environment, emerging life science companies run lean, particularly in terms of personnel. However, the complexities of...Read More