Regulatory Affairs Expert Witnesses in Kentucky

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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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  • FDA Medical Device Regulatory Requirements Expert Witness

    Review Fee $600/hr
    Deposition Fee $750/hr
    Court Fee $750/hr

    This highly qualified expert has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has 18 years of industry experience as a mid-level Manager and Senior Executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions, and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. Currently, he is an Industry Consultant with a leading FDA consulting corporation.

    Industry Consultant, An FDA consulting corporation

    Bachelor of Arts (BA), California State University

    East Alton,

    Illinois

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  • Construction safety & OSHA regulations Expert Witness

    Review Fee $150/hr
    Deposition Fee $150/hr
    Court Fee $150/hr

    This qualified expert received his BA from Valparaiso University and is a licensed OSHA trainer for numerous courses. He has managed various construction safety projects including the installation and modification of industrial equipment valued at over a billion dollars. Formerly, he served as a night safety manager for Gallagher Kaiser at General Motors and as a safety manager for NKC American at Toyota Motor Manufacturing. He currently is the safety manager for a prominent aluminum manufacturer overseeing the installation of a new stamping bed.

    Safety Manager, A construction services organization in TN

    Juris Doctor (JD), Ave Maria School of Law

    Mount Juliet,

    Tennessee

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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.

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