FDA Regulations Expert Witnesses in Georgia

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FDA regulations expert witnesses practice in a variety of fields, including pharmaceuticals, food safety, medical devices, biotechnology, and cosmetics. Some of the most common FDA regulations expert witness specialties also include drug safety, labeling compliance, dietary supplements regulation, clinical trials oversight, and quality control. They can opine on the effects of regulatory compliance, product recalls, adverse event reporting, Good Manufacturing Practices (GMP), and new drug approval processes.

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Average FDA Regulations Expert Witnesses Court Fees

$450/hr

Review Fee

$525/hr

Deposition Fee

$550/hr

Court Fee

FDA Regulations Experts in Georgia

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This expert's professional career has spanned 50 years, while for the past 20 years he has specialized in guiding companies through the CE marking process for products prepared to enter the EU market and for companies in the US who want CE marking on their products for market flexibility and/or liability protection, many of which are medical devices and machinery. This expert conducts forensic legal analysis of companies' Quality Management Systems (ISO 9001), Environmental Management Systems (ISO 14001), and Quality System Regulations as stipulated by the FDA. He has hosted over 450 seminars and workshops and has published more than 300 articles and multiple books in the areas of Liability, EU Directives/CE Marking, Technical Standards, FDA Quality System Regulations, and ISO 90001 and 14001. He has developed and delivered on-site training programs on product liability exposure for medical device insurance companies, as well as for corporate counsel, defense counsel, and trial attorneys involved with medical devices and medical device manufacturers. As a Senior Consultant for both Excel Partnerships and SAI Global, he also developed and delivered on-site training programs on CE marking for the Medical Devices Directive and related Quality Management Systems. As Legal Expert/Expert Witness he has prepared legal materials for use in litigation involving Quality Systems and CE marked products as well as EU Administrative Reviews.

Legal Consultant and President, International Standards and Regulations Consulting Firm

Doctor of Philosophy (PhD), University of Kansas

Marietta,

Georgia

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Review Fee $250/hr
Deposition Fee $500/hr
Court Fee $500/hr

This 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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Related Specialties

FAQs for Fda Regulations Expert Witnesses

What is the role of an FDA Regulations expert witness in a legal case?

An FDA Regulations expert witness provides insight on compliance, regulatory standards, and industry practices. They can testify on violations, product safety, and approval processes.

What types of cases might require an FDA Regulations expert witness?

Cases involving pharmaceuticals, medical devices, food safety, dietary supplements, cosmetics, or any product regulated by the FDA may require such an expert witness.

Can an FDA Regulations expert witness help with cases related to drug approval processes?

Yes. These experts can provide valuable insights into the complex process of drug approval and how deviations from this process can lead to legal issues.

Are there subspecialties within the field of FDA Regulations for expert witnesses?

Yes. Subspecialties can include pharmaceutical regulations, food safety standards, medical device regulations, cosmetic regulations, and more.

How can an FDA Regulations expert witness assist in a case involving adverse drug reactions?

They can evaluate whether the manufacturer complied with FDA regulations regarding reporting adverse events and if failure to comply contributed to harm.

How does Expert Institute select its FDA Regulations expert witnesses?

Expert Institute offers a personalized approach to help you find the highest quality experts. We source actively-practicing professionals who match all your requirements for specialty areas, work experience, litigation history, fee range, certifications, location, and more.

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