Regulatory Affairs Expert Witnesses in New Jersey

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Regulatory affairs expert witnesses practice in a variety of fields, including pharmaceuticals, medical devices, biotechnology, and healthcare compliance. Some of the most common specialties include FDA regulations, EMA guidelines, product approvals, labeling, advertising, and post-market surveillance. They can opine on the effects of regulatory noncompliance, enforcement actions, product recalls, and patient safety risks.

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Regulatory Affairs Experts in New Jersey

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Regulatory Insurance Expert Witness
Regulatory Insurance Expert Witness
Review Fee
$400/hr
This highly qualified expert has over 30 years of experience as an insurance regulator and consultant. He earned his BS in commerce from Rider College. He is an accredited insurance examiner and is a member of the Statutory Accounting Working Group and NAIC Financial Analysis Working Group. He was formerly an assistant chief insurance examiner for the financial analysis unit, at the New Jersey Department of Banking and Insurance. Additionally, he was an assistant commissioner and the chief insurance examiner for the office of solvency regulation at the New Jersey Department of Banking and Insurance. He is currently a managing member of an insurance regulation and compliance service company.
Managing Member, An insurance regulation and compliance service company in NJ
Bachelor of Science (BS), Rider College
Lumberton,
New Jersey
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New York State DMV Regulations Expert Witness
New York State DMV Regulations Expert Witness
Review Fee
$300/hr
Deposition Fee
$400/hr
Court Fee
$400/hr
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
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Pharmacy Regulations Expert Witness
Pharmacy Regulations Expert Witness
Review Fee
$150/hr
Deposition Fee
$150/hr
Court Fee
$200/hr
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.