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
Outsourcing Contact Center Interactions for PV, DV, CM, and MI
Client Mid-size Industry Pharmaceutical and Medical Devices Business Challenge Develop a sustainable operational business model for PV, DV, CM, and MI that will meet increasing business demands and escalating regulatory requirements. Project Timeline Pre-Implementation Due Diligence – 3 Months Pilot...Read More
Biosimilar Drug Development
Client Challenge A European based company engaged in biosimilar drug development requested RCA to develop a regulatory strategy, whereby they...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