The staff at PDG is highly proficient in the compilation of targeted and effective Citizen Petitions addressed to…
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 navigates the complexities of the US pharmaceutical industry for clients through our strategic drug development services that include analysis of commercial potential during early stages of clinical development in parallel with regulatory planning. Continue reading
PDG provides litigation support and research, as well as expert testimony, to the legal community for qualifying cases.
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.