Nda Expert Witnesses
Nda expert witnesses and consultants listed here may be able to form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts on nda. The nda expert witness listings on this page are typically from fields/areas of expertise such as: Computers, Manufacturing, Pharmaceutical Regulation, and Software Engineering.
Timothy A Anderson
Chemistry and Manufacturing Controls (CMC), FDA
The AquaMarine Group, Inc.
Redding, Connecticut
Pharmaceutical Regulation, Manufacturing
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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...
Dennis E Dombkowski
WTM Solutions LLC
Albuquerque, New Mexico
Software Engineering, Computers
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Software Misappropriation, Web, Mobile, Artificial Intelligence, Wi-Fi, Smartphone, Database, C#, JavaScript, SQL, Open Source, NDA, HTML, API Security, Software Development, Source Code, Information Technology, Software Security, Python
Dennis has worked in the field of software engineering for nearly 20 years. He has worked in database design, APIs, and frontend frameworks, often focused on one category at a time. However, he has also found himself in positions where he acts as a ‘full stack developer’, or a developer that touches all aspects of a large application, from frontend website work to database design.
His experience includes being a heads-down software engineer as well as a leader and mentor. He has vast amounts of experience in explaining highly technical terminology and concepts to non-technical people, such as Product Owners and Project Managers.
Dennis has a genuine love for technology. He strives to continually improve himself by learning new skills, technologies, languages, frameworks, and techniques.
