Regulatory Affairs Expert Witnesses in Florida

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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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Average Regulatory Affairs Expert Witnesses Court Fees

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Regulatory Affairs Experts in Florida

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  1. Workers Compensation & Regulatory Compliance Expert Witness

    Review Fee
    $350/hr
    Deposition Fee
    $350/hr
    Court Fee
    $350/hr

    This highly-qualified expert in arbitration and mediation has over 25 years of experience. She earned her BA in philosophy at College of William and Mary and her JD at the University of Richmond. She is a certified mediator with the Florida Supreme Court and a certified arbitrator with AIDA Reinsurance & Arbitration Society. She is active in her field as a member of the Association of South Florida Mediators and the Chartered Property Casualty Underwriter Society. She has formerly served as the chair of the tort and insurance practice section for the American Bar Association and as an attorney in the insurance transactional and regulatory practice at Adorno & Zeder, P.A. In addition, she spent nearly 20 years working for the National Council on Compensation Insurance, where she served in several legal business positions. She currently serves as the owner of her own firm that provides arbitration, mediation and consulting in Florida.

    Arbitrator/Mediator, A dispute resolution firm in FL

    Juris Doctor (JD), University of Richmond

    Pompano Beach,

    Florida

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  1. Pharmaceutical & FDA Regulations Expert Witness

    Review Fee
    $250/hr
    Deposition Fee
    $500/hr
    Court Fee
    $500/hr

    This expert has over 40 years of experience in the Pharmaceutical and Pharmaceutical Packaging industries. He has published five books and has instructed professionals at the graduate level in Quality Assurance and Regulatory Affairs at a major university's pharmacy school. As a former Director of the Science Branch of the Philadelphia District FDA, he directed a laboratory staff of 30 in methods verification of New Drug Applications and Abbreviated New Drug Applications, Drug Product Surveys, and Research Projects. Currently, this expert is an independent consultant in which he assists pharmaceutical firms in technical, regulatory, and management areas to ensure their clients' products hit the market in a timely manner. He assists attorneys as an Expert Witness/Subject Matter Expert in Pharmaceutical cases.

    Founder/Principal, A consulting services for pharmaceutical firms

    Master of Business Administration (MBA), Temple University

    Savannah,

    Georgia

What Can a Regulatory Affairs Expert Witness Opine On?

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.

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