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This expert received his undergraduate and doctoral degrees in Biomedical Engineering from Iowa State University. He has worked for and consulted with leading medical device, pharmaceutical & biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the FDA, Health Canada, the US & European Patent Offices, the Centers for Medicare and Medicaid Services, and other regulatory agencies around the world. As an internationally recognized expert, he presents frequently on cutting-edge medical technologies and conducts seminars for medical device, pharmaceutical and biotechnology companies.
Adjunct Professor, A top university in DC and a medical school in PA
Doctor of Philosophy (PhD), Iowa State University
Carlsbad,
Massachusetts
This former New York DMV manager has decades of experience working for the Department of Motor Vehicles. He held positions as a Clerk and Operations Manager in the White Plains and Albany offices in the 1980s and became Office Manager of the New York District Office in 1993. For 12 years, he served as the District Director in charge of operations in the MetroNorth District, and he finished his career in the DMV as the Regional Director in charge of the Metropolitan Region from 2008 until 2012. After leaving the DMV, the expert briefly served on a county legislature; he now works in the insurance industry.
Account Representative, A Large Insurance Company
Cornell University Extension
Congers,
New York
This extremely qualified expert is a certified pharmacist with years of experience in community pharmacy management and regulatory affairs. He received both his BS degree in pharmacy and his MBA degree from the University at Buffalo. He is a member of multiple professional associations, including the American Association of Colleges of Pharmacy, the American Pharmacists Association and the American Society for Pharmacy Law. He has given 100+ lectures statewide in NYS. His outstanding work has earned him several honors, including the Pharmacists Society of the State of New York's "Faculty Excellence Award" the Pharmacists Association of Western New York's "Pharmacist of the Year" award and the national Bowl of Hygeia award. He is the former coordinator of pharmacy services at the Community Health Center of Buffalo. He is also the former director of pharmaceutical care services at the University of Buffalo. Currently, he is a clinical associate professor of pharmacy practice and administration at a major university, where he also serves as the senior associate dean of the pharmacy school's student, professional and community affairs.
Senior Associate Dean, School of Pharmacy, Major University
Master of Business Administration (MBA), University at Buffalo
Getzville,
New York
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What Can a Regulatory Affairs Expert Witness Opine On?
Regulatory Submissions
Prepare and submit regulatory documents.
Labeling Compliance
Ensure product labels meet regulations.
Risk Assessment
Evaluate potential risks of products.
Clinical Trial Applications
Submit applications for clinical trials.
Quality Management Systems
Implement and maintain quality systems.
Regulatory Strategy Development
Create strategies for regulatory approval.
FAQs for Regulatory Affairs Expert Witnesses
What is a regulatory affairs expert witness?
A regulatory affairs expert witness is a specialist in FDA, EMA, and other compliance rules who explains standards and industry practices. They assist by reviewing records, preparing reports, testifying, and clarifying complex regulatory issues.
In what case types can a Regulatory Affairs expert witness provide valuable assistance?
A Regulatory Affairs expert witness assists in FDA and EMA compliance, drug and device approval, labeling, clinical trials, pharmacovigilance, manufacturing, and product liability cases.
How can a regulatory affairs expert witness evaluate FDA compliance in disputed submissions?
A regulatory affairs expert witness evaluates FDA compliance in disputed submissions by reviewing documentation, regulations, correspondence, and processes to identify gaps and support or challenge claims.
What qualifications should counsel require from a regulatory affairs expert witness?
Counsel should require a regulatory affairs expert witness to have advanced regulatory credentials, industry experience, prior testimony, and deep knowledge of relevant agency rules.
How does a regulatory affairs expert witness assess adequacy of product labeling controls?
A regulatory affairs expert witness assesses adequacy of product labeling controls by reviewing procedures, change controls, training, audits, and compliance with FDA and industry standards.
What is Expert Institute’s process for selecting regulatory affairs 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.