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 provides litigation support and research, as well as expert testimony, to the legal community for qualifying cases.
The industry professionals at PDG conduct high quality international Literature search services across a variety of medical and scientific databases. Customized and Targeted Literature Search Services In providing Literature search services, PDG employs customized and targeted search methods, summary and analyses, extensive electronic library and multi-lingual translation options. Our methods are highly cost-effective and routinely…
Imagine the value of continuous access to the specialty pharmaceutical consulting services and resources necessary to complete tasks that are out of the ordinary, unexpected, or for which you just don’t have time.
In our capacity as a pharmacokinetic consultant to both ANDA and NDA sponsors, PDG has participated in all phases of the regulatory and development processes.
For over 15 years, PDG has helped pharmaceutical firms achieve and maintain compliance with global Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and pharmacovigilance (PV) standards.
PDG’s experienced technical writers include scientists and industry professionals who routinely draft and compile persuasive regulatory and scientific analyses. Our depth of experience in the preparation of such material positions us to address your communication needs in a variety of ways.
Years of service to the pharmaceutical industry, across a diverse range of drug development projects, has taught PDG that supplier/vendor selection, audit, qualification, contract negotiation, and oversight are critical to a successful drug development program.
PDG Provides Strategic Toxicology Consulting from Development through NDA Submission In terms of strategy, one of PDG’s most critical functions is attempting to reduce toxicology study requirements. For example, in a recent meeting with FDA, we presented data in support of waiving the carcinogenicity requirements for a new drug product. Our presentation consisted of an…