Changes Being Effected (CBE)
As pharmaceutical consultants, PDG has reported extensively on FDA’s Proposed Rule entitled Supplemental Applications…
India’s Pharma Industry Faces Unprecedented Challenges
India’s pharmaceutical industry has grown at record levels in recent years…
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.
PDG’s team of industry professionals has extensive experience in planning Pre-IND Meetings on our clients’ behalf (as well as other Type B Meetings). Continue reading
First, PDG will help you determine if an IND is required. FDA Guidance notes that there are times…
PDG designs and executes preclinical and clinical (Phases I-IV) programs associated with pharmaceutical product development and the securing…
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.
Many PDG clients have found the 505(b)(2) NDA development pathway to be a more timely and cost-effective route to market. Continue reading
PDG and staff have participated in over one hundred 505(j) Abbreviated New Drug Applications (ANDA) submissions.