It is my belief that if your company does not feel comfortable interacting with the FDA, your company is headed for problems down the development road. I have interacted with the FDA during the development of gabapentin, atorvastatin and quinapril. I have found the agency to be reasonable while maintaining high standards. In all cases, the API part of the NDA filing and subsequent compliance inspection went smoothly, and did not result in any approval delays.

I have experience preparing the API portion of regulatory filings, and can assist your company in preparing regulatory filings, if needed. I have experience in preparing for EofP II meetings with the FDA, including preparing the pre-meeting monograph.