Regulatory Affairs Expert Witnesses in Wyoming

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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 Regulation & Compliance Expert Witness

    Review Fee $400/hr
    Deposition Fee $500/hr
    Court Fee $500/hr

    This FDA regulation expert earned her B.S. in Environmental Chemistry from Purchase College and her M.S. in Environmental Science from the University of Colorado Denver. She began her career with the FDA in 1987 as a Chemist in the Denver Districts Laboratory and then became a Compliance Officer in 1992, specializing primarily in medical device and biologics cases. She later managed a group of eight investigators as a Supervisory Consumer Safety Officer and then became a Compliance Officer, tasked with evaluating reports and lab analysis to determine compliance with regulation. The expert finished her FDA career as a Senior Case Review Expert, a role she held from 2008 until the end of 2015. In this position, she was responsible for reviewing and evaluating proposed judicial actions to determine if they were compliant with the requirements of the the Federal Food, Drug, and Cosmetics Act and other regulations. Currently, the expert runs her own consulting business.

    Principal and Owner, A Regulatory Compliance Consultancy in CO

    Master of Science (MS), University of Colorado

    Littleton,

    Colorado

    View profile

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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