Pharmaceutical Regulation Expert Witnesses in Connecticut

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: 505(b)(2), Active Pharmaceutical Ingredient, Anda, Api, Bla, C Gmp, Chemistry And Manufacturing Controls, Cmc, Crl, Current Good Manufacturing Practice, Drug Master File, Due Diligence, FDA, Food And Drug Administration, and Label.

Use the search box above to further refine your search for pharmaceutical regulation expert witnesses by keyword and state. Attorneys contact the experts directly – with no middleman.

David B. Ross, MD, PhD, MBI

FDA Regulations & Procedures
Drug Safety, Clinical Trials
10+ Years at FDA (CDER)

Debra Leibold, MD, PhD

Global Labeling Strategist
Pharmaceutical Regulation
Labeling-Regulatory Compliance

Timothy A Anderson

Chemistry and Manufacturing Controls (CMC), FDA

The AquaMarine Group, Inc.

Redding, Connecticut

Pharmaceutical Regulation, Manufacturing - Current Good Manufacturing Practice, ANDA, cGMP, CMC, Active Pharmaceutical Ingredient, Food and Drug Administration, 505(b)(2), NDA, New Drug Application, NCE, Regulatory compliance, BLA, Drug Master File, Method validation, CRL, Due diligence, FDA, Chemistry and Manufacturing Controls, API, label

Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist with over 43 years of career experience in Pharmaceutical R&D, Quality Operations, and Regulatory Affairs. A uniquely inter-disciplined individual, he melds comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials. As a consultant in his own pharmaceutical development advisory firm for over 29 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls (CMC), current Good Manufacturing Practice (cGMP), quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products. Technical and regulatory compliance due diligence services are furnished to institutional investors. Mr. Anderson has contributed to...

Timothy A Anderson - Full Listing and Contact Info

You can also find Pharmaceutical Regulation Expert Witnesses in:

Connecticut, Georgia, Maryland, Massachusetts, New Jersey, Pennsylvania, Texas, and Virginia