Pharmaceutical Development Group travels to your facilities, FDA, foreign regulatory authorities, CROs, CMOs, API suppliers, or wherever the need arises scientists, regulatory professionals and scientific writers
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.
Post-launch activities for a new drug require companies to rigorously track, report, and evaluate worldwide adverse event information. Such drug post-launch activities are critically important to ensure current benefit/risk profiles and the dissemination of labeling that fully describes the safe use of a drug product.
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.
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.
Pharmaceutical Development Group (PDG) assists FDA regulated firms in the navigation of the U.S. submission, approval and post-marketing procedures across a variety of dosage forms and therapeutic areas. Our expertise spans prescription and nonprescription (OTC) drugs, both NDA and monograph, as well as devices.
We focus our experiences and energies to serve as your long-term regulatory partner throughout product lifecycles. PDG will develop strategic plans and lifecycle management options designed to maximize the safety, efficacy, and commercial value of your products.