The staff at PDG is highly proficient in the compilation of targeted and effective Citizen Petitions addressed to FDA. PDG has participated in the compilation, submission and maintenance of multiple petitions. The topic areas have been many and varied including, for example, ANDA suitability petitions, requests for changes in drug labeling, generic drug review standards…
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).
Investigational New Drug Application – First, PDG will help you determine if an IND is required. FDA Guidance notes that there are times when it may not be clear if use of an FDA-regulated product might trigger an IND filing. However, FDA does not charge sponsors for Pre-IND meetings. PDG has orchestrated early stage strategies…
PDG designs and executes preclinical and clinical (Phases I-IV) programs associated with pharmaceutical product development and the securing of FDA approvals for both brand name and generic drug products. Our experienced and professional staff of pharmaceutical scientists and regulatory experts will help you navigate study design challenges across a wide variety of designs. These include,…
Pharmaceutical Development Programs – 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.
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.
PDG and staff have participated in over one hundred 505(j) Abbreviated New Drug Applications (ANDA) submissions.