Regulatory Affairs Expert Witnesses in Colorado
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Regulatory Affairs Experts in Colorado
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FDA Regulation & Compliance Expert Witness
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 eight investigators as a Supervisory Consumer Safety Officer and then became a Compliance Officer, tasked with evaluating reports and lab analysis to determine compliance with regulation. The expert finished her FDA career as a Senior Case Review Expert, a role she held from 2008 until the end of 2015. In this position, she was responsible for reviewing and evaluating proposed judicial actions to determine if they were compliant with the requirements of the the Federal Food, Drug, and Cosmetics Act and other regulations. Currently, the expert runs her own consulting business.
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Principal and Owner, A Regulatory Compliance Consultancy in CO
Master of Science (MS), University of Colorado
Littleton |
Colorado
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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.