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).
Investigational New Drug Application (IND)/Special Protocol Assessment (SPA)
Investigational New Drug Application – First, PDG will help you determine if an IND is required. FDA Guidance notes that there are times when it may not be clear if use of an FDA-regulated product might trigger an IND filing. However, FDA does not charge sponsors for Pre-IND meetings. PDG has orchestrated early stage strategies…
Clinical Trial Design
PDG designs and executes preclinical and clinical (Phases I-IV) programs associated with pharmaceutical product development and the securing of FDA approvals for both brand name and generic drug products. Our experienced and professional staff of pharmaceutical scientists and regulatory experts will help you navigate study design challenges across a wide variety of designs. These include,…
Legal Support
PDG provides litigation support and research, as well as expert testimony, to the legal community for qualifying cases.
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…