Chemistry and Manufacturing Controls (CMC), FDA
Contact this Expert Witness
- Company: The AquaMarine Group, Inc.
- Phone: (203) 241-5864
Specialties & Experience of this Expert Witness
General Specialties:
Pharmaceutical Regulation and ManufacturingKeywords/Search Terms:
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, labelEducation:
BS, Biology, Virginia Commonwealth University; BS, Chemistry , Virginia Commonwealth University; MS, Biochemistry, New York Medical College; MBA, International Business, University of BridgeportYears in Practice:
43Number of Times Deposed/Testified in Last 4 Yrs:
6Additional Information
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 regulatory approvals for over 50 drug and drug / device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and has provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues. Litigation Support - Mr. Anderson has been deposed, testified in Federal Court, and at arbitration, and functioned as a Subject Matter Expert Witness and consultant to litigation in over 20 cases in the Pharmaceutical, Biologic, and Device Life Sciences space, focused in areas of Antitrust, Patent, and Product Liability.