PDG has extensive experience in the development of drug/device combination products and combination drug therapies, including all IND and NDA requirements for both fixed-dose combinations or co-packaged drugs. Continue reading
PDG and staff have participated in over one hundred 505(j) Abbreviated New Drug Applications (ANDA) submissions.
The industry professionals at PDG conduct high quality international literature searches across a variety of medical and scientific…
As regulatory strategists, our view of nonprescription drug development (aka Over-the-Counter or OTC) certainly includes new OTC launches…
Post-launch activities for a new drug require companies to rigorously track, report, and evaluate worldwide adverse event information. Such drug post-launch activities are critically important to ensure current benefit/risk profiles and the dissemination of labeling that fully describes the safe use of a drug product. Continue reading
Our team of full time professional staff and expert consultants are well-versed in the nuances of professional and promotional labeling including website review.
Imagine the value of continuous access to the specialty pharmaceutical consulting services and resources necessary to complete tasks that are out of the ordinary, unexpected, or for which you just don’t have time. Continue reading
In our capacity as a pharmacokinetic consultant to both ANDA and NDA sponsors, PDG has participated in all phases of the regulatory and development processes.
For over 15 years, PDG has helped pharmaceutical firms achieve and maintain compliance with global Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and pharmacovigilance (PV) standards.