Api Expert Witnesses
Api 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 api. The api expert witness listings on this page are typically from fields/areas of expertise such as: Cybersecurity, Information Technology, 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...
Mehdi Tarrit Mirakhorli, PhD
Software Expert Witness, Professor
Honolulu, Hawaii
Software Engineering, Cybersecurity
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Software Development, source code, Artificial Intelligence, Cybersecurity, Software Design, Trade Secret, Database, API, Software, Copy Right, Software programming, Software maintenance, software security, Offensive Security, Defensive Security, AI
Mehdi Tarrit Mirakhorli is software engineering professor in the department of Information and Computer Sciences at University of Hawaii at Manoa. Prior to that Dr. Mirakhorli served as Kodak Endowed Chair, Associate Professor and Director of Research at ESL Global Cybersecurity Institute and Software Engineering Department at Rochester Institute of Technology. Mirakhorli is also the director of Software Assurance Laboratory. He has carried out various projects of national importance in the areas of software engineering, software design, trustworthy software, cybersecurity, Artificial Intelligence (AI) and AI-enabled software. Additionally, Dr. Tarrit Mirakhorli has supported the implementation of President Biden's Executive Order on Improving the Nation’s Cybersecurity.
Dr. Tarrit Mirakhorli, has been ALTA Distinguished Speaker at Alcatel-Lucent, and has delivered numerous technical briefings to public policymakers, members of Congress, government officials, and the general public...
Anton Korenev
Knoxville, Tennessee
Software Engineering, Information Technology
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Software, Internet, Computers, Integration, Web Services, API, Cloud Computing, Software Development, Software Design, Software Architecture, UML, XML, Azure, AWS, C++, C#, .NET, PHP, EDI, SQL
Implemented software solutions using a wide range of (mostly Microsoft) technologies since 1998. Integrating systems since 2001 (XML, GDSN, EDI, web services). Engagements include Nasdaq, Lancôme, McGraw Hill, Johnson & Johnson, Merck, Microsoft, Navigant Consulting, TrueCommerce, United States Golf Association.
AWS Certified Cloud Practitioner
AWS Certified AI Practitioner
