Since 2001, we have helped gain FDA approval for hundreds of medical devices and drugs. We are extremely successful in the regulatory process and love to help our clients accomplish their goals. Our team has the talent and experience to make your project a success.

There's nothing easy about getting a medical device or drug to market. RAA is intimately familiar with the process from start to finish and understands how to guide clients through. Whether an NDA, BLA, ANDA or PMA we've helped a client get approval and will help you as well.

Over the past several years I have had the opportunity to work with Regulatory Affairs Associates on two significant clinical trials which entailed interaction with the Food and Drug Administration. In both instances, RAA had very accurate advice and extremely helpful insights which allowed our research team to successfully navigate the challenging paperwork. As we were very pleased with RAA’s previous performance, we have now obtained their services for another clinical trial in development and things are progressing well.
— Susan R. Mallery

I’d like to thank RAA for helping us survive our first year in business: we went from a few people and an idea to a company with two INDs and a Phase 2 study. And we couldn’t have done this without the tremendous regulatory expertise and efforts from your group.”
— Head of Operations, US start-up pharmaceutical company

What We've Achieved

  • Over 200 companies started due to our FDA guidance, employing over 10,000 people
  • Over 230 510k cleared by FDA in multiple therapeutic categories
  • More than a dozen PMA processed and approved by the FDA
  • More than 140 due diligence regulatory evaluations performed
  • Over 200 successful factory and warehouse audits
  • More than 80 medical devices evaluated and determined to not require pre-market notification or 510k; thereby allowing the company to immediately market their product without FDA review 
  • More than 400 new technologies and patents reviewed for FDA pathway development