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See more Regulatory Affairs Expert WitnessesA 17-year veteran of the U.S. Food and Drug Administration (FDA), this expert served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs, and previously, in scientific, inspectional, compliance and criminal and civil enforcement capacities as an FDA Consumer Safety Officer (CSO), Compliance Officer (CO), a Senior Special Agent (SA) with the Office of Criminal Investigations (OCI) and as an analytical regulatory microbiologist. During his last three years at FDA he spearheaded the agency's integration efforts with Customs and USDA on crosscutting interagency enforcement and operational issues; served as the FDA's point-person in managing the intersection of imports and FDA's new bioterrorism regulations; established joint agency and industry working groups to evaluate counterfeiting and tampering risks to food and drug distribution supply chains; was the agency lead in its strategic planning efforts to reinvent the FDA's import programs; wrote the initial statement of work and acted as program manager over the FDA's new PREDICT, risk-based electronic entry screening system; and directed the development of the FDA's agency-wide Risk-based Import Strategic Plan designed to improve compliance of foods, dietary supplements, drugs, medical devices, cosmetics, and biological products imported into the U.S. As CEO of a FDA consulting firm and Founder of an affiliated law firm, he currently represents domestic and foreign companies of all sizes, assisting them in identifying USDA, FDA, Federal Trade Commission (FTC), Environmental Protection Agency (EPA), and state requirements. He focuses his practice on FDA matters, including but not limited to: matters relating to FDA inspections, FDA criminal, regulatory and administrative enforcement actions for medical devices, drugs, cosmetics, alcohol, tobacco, dietary supplements, and foods.
Owner and Principal, An FDA and USDA regulatory legal practice in DC
Juris Doctor (JD), University of Miami School of Law
Annapolis,
Maryland
This expert received his BA from Cornell University, and his MD and PhD from Albert Einstein College of Medicine. He completed his residency in Psychiatry at UCLA Neuropsychiatric Institute/Brentwood VA Medical Center. He is also a member of numerous academic societies including American Society of Addiction Medicine, American Academy of Addiction Psychiatry, Society of Biological Psychiatry, College of Problems of Drug Dependence and American Psychiatric Association. He has been highly prolific in his career with over 170 publications. He is a currently a Professor of Psychiatry at an academic medical center.
Professor, An Academic Medical Center in MD
Doctor of Philosophy (PhD), Albert Einstein College of Medicine
Pikesville,
Maryland
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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.