PD Groups Profil

Pharmaceutical 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.

Pharmaceutical regulatory consulting

Medical device consulting

ind consulting

Pharmaceutical scientist

Drug monograph format

Adaptive design clinical trials

Post marketing safety surveillance

Regulatory affairs services

Clinical research consultant

510(k) submission