Profile
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. Pharmaceutical regulatory consulting Medical device consulting ind consulting Pharmaceutical scientist Drug monograph format Adaptive design clinical trials Post marketing safety surveillance Regulatory affairs services 513(g) 510(k) submission Pharmacovigilance consultants
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