Regulatory Affairs Expert Witnesses in Maryland

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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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Mr Steven David SilvermanView profile

ID: 6743128

Mr. Steven Silverman, JD

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Maryland

Mr. Steven D. Silverman has 31 years of experience in Healthcare Regulatory and Compliance. He earned his BA from the University of Michigan and his JD from the University of Pennsylvania Carey Law School. Today, this expert is licensed as an Admission to Practice Law in the District of Columbia. Formerly, this expert served as the Director of the Center for Devices and Radiological Health of the...

FDA Regulatory Affairs Expert WitnessView profile

E-057945

FDA Regulatory Affairs Expert Witness

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Maryland

A 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...

Dr Christine Lynn BrauerView profile

ID: 518086

Dr. Christine Brauer, PhD, MS

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Maryland

Dr. Christine L. Brauer has 34 years of experience in Medical Devices and Healthcare Regulation & Compliance. She earned her BA in Biology from the University of Delaware, her MS in Microbiology and Molecular Biology from the University of Virginia, and her PhD in Women's Health and Research Methods from the University of Maryland, College Park. Formerly, this expert served as the Vice President...

Clinical Psychopharmacology & Clinical Research Expert WitnessView profile

E-082090

Clinical Psychopharmacology & Clinical Research Expert Witness

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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,...

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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