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 leverages its experience in helping clients locate, evaluate, qualify and select these important resources. Once selected, PDG routinely serves as the client contact for FDA, clinical research organizations (CROs), contract manufacturing organizations (CMOs), active pharmaceutical ingredient (API) & component suppliers, clinical and non-clinical laboratories. We maintain relationships with such third party organizations to ensure their adherence to sponsor protocols, schedules, budgets, GCPs, GLPs, and GMPs as applicable. It is not unusual for PDG to revise a study protocol, visit a study site or audit an API facility. PDG clients span the globe and count on us for rapid availability and accessibility. Our team is always prepared to travel to your facilities, their facilities or wherever the need arises.