Regulatory Affairs Expert Witnesses in Georgia

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Regulatory Affairs expert witnesses practice in a variety of fields, including pharmaceuticals, medical devices, biotechnology, food safety, and environmental regulations. Some of the most common specialties among Regulatory Affairs expert witnesses include clinical trials regulation, drug approval processes, FDA compliance, product labeling regulations, and quality assurance. They can opine on the effects of regulatory violations, non-compliance penalties, product recalls, adverse event reporting, and regulatory strategy development.

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Regulatory Affairs Experts in Georgia

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Pharmaceutical & FDA Regulations Expert Witness

Pharmaceutical & FDA Regulations Expert Witness

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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FAQs for Regulatory Affairs Expert Witnesses

What is the role of a Regulatory Affairs expert witness?

A Regulatory Affairs expert witness provides insight and testimony on matters related to regulatory compliance, product approval processes, and industry standards in various sectors.

In what types of cases can a Regulatory Affairs expert witness be beneficial?

These experts are crucial in cases involving pharmaceuticals, medical devices, food safety, environmental regulations, and any sector where regulatory compliance is key.

How can a Regulatory Affairs expert witness assist in a pharmaceutical case?

They can provide insights into FDA approval processes, drug safety regulations, labeling requirements, and other aspects of pharmaceutical regulatory affairs.

Are there subspecialties within the field of Regulatory Affairs that an expert witness might focus on?

Yes, some experts may specialize in specific areas like pharmaceuticals, medical devices, biotechnology, or environmental regulations depending on their experience.

Why is it important to have a Regulatory Affairs expert witness with industry-specific knowledge?

Industry-specific knowledge ensures the expert is familiar with the unique regulatory landscape of that sector, providing accurate and relevant testimony.

How does Expert Institute select its Regulatory Affairs 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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