About PDG – An FDA Regulatory Consultant

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.

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.  We can quickly and efficiently address unexpected emergencies.  PDG maintains 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 receive 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, as your FDA regulatory consultant, PDG is always ready to respond without delay.

 

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.

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 products.