Pharmaceutical Development

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
IND consulting

Pharmaceutical strategy consulting
505(b)(2) NDA
505(b)(2)
Pharmaceutical industry news
generic drug product development

fast track designation

fixed combination drug development
510(k) submissions
drug supplier selection
pharmacokinetics in drug development
exempt devices
clinical trial design
Adaptive design clinical trials