Regulatory Affairs Expert Witnesses in Colorado

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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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FDA Regulation and Compliance Expert WitnessView profile

E-065690

FDA Regulation and Compliance Expert Witness

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Colorado

This FDA regulation expert earned her B.S. in Environmental Chemistry from Purchase College and her M.S. in Environmental Science from the University of Colorado Denver. She began her career with the FDA in 1987 as a Chemist in the Denver Districts Laboratory and then became a Compliance Officer in 1992, specializing primarily in medical device and biologics cases. She later managed a group of...

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Regulatory Affairs Expert Witness FAQs

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

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

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

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

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

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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