Drug Post-Launch Activities
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.
Strategic Drug Development Services
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.
Quality Assurance & Compliance
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.
Specialty Services
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.
At PDG we focus our wide ranging industry experience and energies on service as your long-term regulatory partner throughout the lifespans of your products. PDG will develop strategic plans and lifecycle management options designed to maximize the safety, efficacy and commercial value of your products. PDG will also take over where other consultants have not optimally performed. In fact, PDG has successfully facilitated FDA meetings (including repeats due to other’s failures) where the agency has adopted all of our regulatory or scientific initiatives.
While PDG possesses the resources and experience to address large scale development projects, long-term regulatory strategies and complex non-clinical and clinical issues, we remain as nimble and responsive as the day of our founding. Essentially, we can also quickly and efficiently address an unexpected emergency. At PDG, we maintain a posture of readiness to react and respond to your needs and regulatory urgencies 24 hours a day, 7 days a week. We recognize that you may have just received an FDA Form 483 or Warning Letter, may be faced with the possibility of a recall, or have encountered some other sudden and urgent situation. Regardless of the emergency, PDG is always ready to respond without delay.
PDG’s clients span the globe and count on us for rapid availability and accessibility. Our team is always prepared to travel to your facilities, FDA, CROs, CMOs, or wherever the need arises. Join other successful companies who have chosen PDG to serve as a long-term partner in the maximization of the value of their drug, device and biologic products.