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.
International and U.S. companies rely on the expertise and professional resources of PDG to provide dependable, accurate and compliant drug safety programs, pharmacovigilance services and ongoing assessments of labeling accuracy and completeness. An Experienced Post-Marketing Safety Surveillance Team PDG’s array of epidemiologists, clinicians, statisticians, and regulatory experts deliver evidence-based analyses to address the safety and…Details
Our team of full time professional staff and expert consultants are well-versed in the nuances of professional and promotional labeling including website review.
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 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