PDG provides pharmaceutical strategy and development consulting expertise and serves as our clients’ regulatory voice at FDA. Whether you require a 505(b)(1) or 505(b)(2) NDA, PDG employs pharmaceutical industry professionals who routinely and successfully present client-proposed regulatory strategies to the Agency.
Pharmaceutical Development Programs – The importance of pharmaceutical industry experience at this critical juncture in the drug development program cannot be understated.
PDG has participated in multiple NDAs (505(b)(1) and 505(b)(2)) and sNDAs, including first-in-class drug products, new chemical entities, Rx-to-OTC switches, and fixed-dose combinations.
PDG has extensive experience in the development of drug/device combination products and combination drug therapies, including all IND and NDA requirements for both fixed-dose combinations or co-packaged drugs.
PDG and staff have participated in over one hundred 505(j) Abbreviated New Drug Applications (ANDA) submissions.
As regulatory strategists, our view of non prescription drug Product development (aka Over-the-Counter or OTC) certainly includes new OTC launches and Rx-to-OTC switches. However, there are many lesser known nonprescription OTC drug development opportunities that PDG can help with. Click through these four Q&As to learn more. As you do so, keep in mind…