Pharmaceutical Regulation Expert Witnesses in Virginia

The SEAK Expert Witness Directory contains a comprehensive list of pharmaceutical regulation expert witnesses who testify, consult and provide litigation support on pharmaceutical regulation and related issues. Pharmaceutical regulation expert witnesses and consultants on this page may form expert opinions, draft expert witness reports, and provide expert witness testimony at deposition and trial. The issues and subjects these pharmaceutical regulation expert witnesses testify regarding may include: Antimicrobials, Antiseptics, Biochemistry, Biological Defense, Biologics, Clinical Trials, Dairy Micro, Data Fraud, Disinfectants, Drug Development, Drug Labels, FDA, Food Poisoning, Ip, and Medical Devices.

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Peter Coderre, PhD

Antimicrobial Regulatory Consulting

Lovettsville, Virginia
Pharmaceutical Research, Infectious Diseases - pharmaceutical regulation, FDA, drug development, antimicrobials, antiseptics, disinfectants, clinical trials, post-marketing surveillance, drug labels, biologics, medical devices, microbiology, biochemistry, molecular biology, food poisoning, data fraud, biological defense, dairy micro, IP
25 years of experience in infectious disease including food microbiology, chemical/ biological defense and regulatory science. Initial employment in the Federal Government was with the Agricultural Research Service (ARS) performing genetic engineering of dairy bacteria. From there, he went to the Department of Defense, specifically Naval Surface Warfare Center (NSWC), working in chemical and biological warfare defense. Spent 12 years as a Clinical Microbiology reviewer in the Center of Drug Evaluation and Review (CDER) at FDA. He has extensive experience with FDA submissions including: pre-IND, IND, NDA, labeling supplements, and post-marketing for antibiotics, topical antiseptics, biologics and generic drugs. As an independent consultant, provided guidance on microbiology and regulatory affairs for clients developing antimicrobials, medical devices and biologics allowing clients to navigate through the FDA regulatory process. This guidance included providing advice for deve...
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