Regulatory Affairs Expert Witnesses in Minnesota
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FDA Regulations Congressional oversight Expert Witness
Review Fee $500/hrDeposition Fee $500/hrCourt Fee $500/hrThis 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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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.