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.

Regulatory Affairs Expert Witnesses in Wisconsin

Average Regulatory Affairs Expert Witnesses Court Fees

Review Fee

Deposition Fee

Court Fee

Regulatory Affairs Experts in Wisconsin

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FDA Regulatory Policy and Congressional Oversight Expert Witness
FDA Regulatory Policy and Congressional Oversight Expert Witness
Review Fee
$500/hr
Deposition Fee
$500/hr
Court Fee
$500/hr
This expert is the president of a healthcare government relations and regulatory policy consultancy firm that she founded after an extensive career in healthcare and government. She was the Vice President for Government Relations and Public Policy at Celgene and was the Vice President for Regulatory Policy at GE Healthcare. She served in the administration of President George H.W. Bush as Special Assistant for Legislative and Public Affairs in the Office of the Commissioner, US Food and Drug Administration. She is a certified Regulatory Affairs specialist and is the author of numerous reports and is currently on the Board of Directors of the FDA Alumni Association. Her formal education includes a BA in Government from Georgetown University and an MS in Science and Technology Commercialization from The University of Texas at Austin.
President, A Biotech Consultancy
Master of Science (MS), University of Texas at Austin
Milwaukee,
Wisconsin
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FDA Medical Device Regulatory and Clinical Trials Expert Witness
FDA Medical Device Regulatory and Clinical Trials 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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What Can a Regulatory Affairs Expert Witness Opine On?

Regulatory Strategy Development
Assess appropriateness of approval, clearance, or pathway choices.
FDA Submission Preparation
Evaluate 510(k), PMA, NDA, BLA content, structure, and adequacy.
Labeling and Promotional Review
Opine on labeling, claims, and ads for regulatory compliance.
Clinical Trial Regulatory Oversight
Assess IND/IDE filings, trial conduct, and GCP compliance.
Postmarket Surveillance Systems
Review complaint handling, vigilance, and safety reporting.
Regulatory Compliance Programs
Evaluate SOPs, training, audits, and interactions with agencies.

FAQs for Regulatory Affairs Expert Witnesses in Wisconsin

What qualifications do regulatory affairs expert witnesses in Wisconsin typically hold?

Regulatory affairs experts in Wisconsin typically hold advanced degrees in fields like pharmacology or law, and may have experience with the University of Wisconsin System.

Are Wisconsin regulatory affairs experts usually licensed or certified in specific professional fields?

These experts often have certifications like RAC and may be licensed in related fields such as pharmacy or law.

How does experience with Wisconsin healthcare systems impact a regulatory affairs expert’s testimony?

Experience with Wisconsin healthcare systems like UW Health can enhance an expert's testimony by providing insight into regional regulatory practices.

Do regulatory affairs expert witnesses in Wisconsin often have academic or university affiliations?

Many have affiliations with academic institutions such as the University of Wisconsin-Madison, contributing to their expertise.

What types of industries in Wisconsin commonly employ regulatory affairs professionals who serve as expert witnesses?

Industries like biotechnology and medical devices in Milwaukee and Madison commonly employ regulatory affairs professionals who may serve as expert witnesses.

How can I find a regulatory affairs expert witness who actively practices in Wisconsin?

You can find practicing regulatory affairs experts through Wisconsin-based directories or associations like BioForward Wisconsin.

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Wisconsin Regulatory Affairs Expert Witnesses

Regulatory Affairs Expert Witnesses in Wisconsin

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Regulatory Affairs Experts in Wisconsin

FDA Regulatory Policy and Congressional Oversight Expert Witness

FDA Regulatory Policy and Congressional Oversight Expert Witness

Find Regulatory Affairs Expert Witnesses in nearby states

FDA Medical Device Regulatory and Clinical Trials Expert Witness

FDA Medical Device Regulatory and Clinical Trials Expert Witness

Find Regulatory Affairs Expert Witnesses In:

What Can a Regulatory Affairs Expert Witness Opine On?

Regulatory Strategy Development

FDA Submission Preparation

Labeling and Promotional Review

Clinical Trial Regulatory Oversight

Postmarket Surveillance Systems

Regulatory Compliance Programs

FAQs for Regulatory Affairs Expert Witnesses in Wisconsin

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