The FDA approval process is the Gold Standard for health care product approval. Regulatory Affairs Associates knows the system 'inside out' and how to make it work for your project.

Regulatory Affairs Associates optimizes efficiency with a team of highly experienced experts. Our clients are delighted by our attention to detail and unsurpassed results in Drug and Medical Device approval. 

Regulatory Affairs Associates is the premier FDA Consulting Company, with FDA Consultant expertise gaining FDA approval for medical devices, drugs and nutritional supplements. Our FDA Consultants have achieved over 240 government approvals in the USA and around the world, helping to create 200 new successful companies.




Find out about our organization, our methods, and the results of our decades of experience as FDA consultants.

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Drug Approval Expertise

We know what steps need to be taken to get drugs approved by the FDA and to market.

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MEdical Device expertise

We have an abundance of knowledge getting medical devices to market and can help you every step of the way.

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We are experts when it comes to getting your international regulation approval.

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