Pre-IND Meetings
PDG’s team of industry professionals has extensive experience in planning Pre-IND Meetings on our clients’ behalf (as well as other Type B Meetings).
Pharmacokinetic Consulting
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.
Toxicology NDA Consulting
PDG Provides Strategic Toxicology Consulting from Development through NDA Submission In terms of strategy, one of PDG’s most critical functions is attempting to reduce toxicology study requirements. For example, in a recent meeting with FDA, we presented data in support of waiving the carcinogenicity requirements for a new drug product. Our presentation consisted of an…