Regulatory Affairs

Our Regulatory Affairs Team consists of seasoned leaders and professionals well-versed in providing the roadmaps to obtaining FDA marketing approvals for parenteral drug products.

We leverage our knowledge from countless ANDA and NDA submissions and approvals to strategize the most efficient pathway for each drug product. 

We maintain compliance by submitting post-approval filings such as annual reports, renewals, notifications and amendments.

We are compliant experts that provide regulatory CMC guidance throughout the drug product development and post-approval processes.