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 assists the pharmaceutical industry to develop and maintain prescription and non-prescription drug products and devices. Not surprisingly, we engage in a variety of regulatory activities involving literature searches and data evaluations to accomplish these tasks. On any given day you might find our staff developing Pre-IND/NDA meeting packages, developing FDA correspondence and regulatory submissions,…Details
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…Details