Regulatory Affairs Expert Witnesses in South Carolina
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Average Regulatory Affairs Expert Witnesses Court Fees
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Pharmaceutical & FDA Regulations Expert Witness
Review Fee $250/hrDeposition Fee $500/hrCourt Fee $500/hrThis 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
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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.