FDA Regulations Expert Witnesses in Connecticut
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Average FDA Regulations Expert Witnesses Court Fees
$450/hr
Review Fee
$525/hr
Deposition Fee
$550/hr
Court Fee
Find FDA Regulations Expert Witnesses in nearby states
Chemistry & Pharmaceuticals Expert Witness
Review Fee $500/hrDeposition Fee $600/hrCourt Fee $600/hrThis highly-qualified expert in chemistry and pharmaceuticals has 20 years of experience in his field. He has experience with analytical chemistry analysis, formulation chemistry, and FDA regulation, and his work has involved in all aspects of drug research and development from synthesis/purification, in-vitro, in-vivo (efficacy, pharmacokinetics and pharmacodynamics) testing, dosing routs, drug formulation, stability studies and the management of CROs. He earned his BA in chemistry from Rhode Island College before earning his PhD in chemistry from Brown University. He formerly served as a scientist at Eikos Inc and as the principal scientist and project coordinator at Paratek Pharmaceuticals. He then worked as a consultant in pharmaceutical development for H-3 Biomedicine and Cemotics. Currently, this expert is a professor of chemistry at a college and a pharmaceutical advisor at a consultancy in Rhode Island.
Consultant, A Pharmaceutical Consultancy in RI
Doctor of Philosophy (PhD), Brown University
Providence,
Rhode Island
Related Specialties
Find Fda Regulations Expert Witnesses In:
What Can a FDA Regulations Expert Witness Opine On?
New Drug Application (NDA)
Process for seeking FDA approval of drugs.
Investigational New Drug (IND) Application
Request to begin clinical trials on drugs.
Biologics License Application (BLA)
Application for approval of biological products.
Abbreviated New Drug Application (ANDA)
Application for generic drug approval.
Food Facility Registration
Registration of food manufacturing facilities.
Labeling Compliance Review
Evaluation of product labeling for compliance.
FAQs for Fda Regulations Expert Witnesses
What is a fda regulations expert witness?
An FDA regulations expert witness is a specialist who explains how FDA laws and compliance standards apply to a case. They assist by reviewing records, preparing opinions, testifying, and clarifying regulatory issues.
What types of cases may benefit from the expertise of an FDA Regulations expert witness?
An FDA regulations expert witness handles cases involving drug and device approvals, labeling, advertising, clinical trials, GMP compliance, recalls, and regulatory enforcement.
How can an FDA-regulations expert witness strengthen regulatory causation arguments?
An FDA-regulations expert witness strengthens regulatory causation arguments by linking specific FDA standards, compliance gaps, and regulatory history directly to the alleged harm.
What qualifications should counsel prioritize when selecting an FDA-regulations expert witness?
Counsel should prioritize an FDA-regulations expert witness with direct FDA or industry experience, advanced regulatory credentials, case-testifying history, and strong scientific or legal training.
How does an FDA-regulations expert witness evaluate compliance with labeling requirements?
An FDA-regulations expert witness evaluates labeling compliance by comparing product labels to FDA statutes, regulations, guidance, and enforcement history to identify gaps or violations.
What is Expert Institute’s process for selecting fda regulations expert witnesses?
Expert Institute delivers a tailored approach to connect you with top-tier experts. We identify actively practicing professionals who meet your exact criteria for specialty, experience, litigation background, fee structure, credentials, location, and more.