Biotech Research Group

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

510(k) submission, Clinical trial design, pharmaceutical strategy consulting