Virginia
Dr. Aloka Srinivasan has 31 years of experience in Pharmaceuticals and Drug Safety. She earned her BS in Chemistry from Presidency University, her MS in Chemistry from the University of Calcutta, and her Ph.D. in Organic Chemistry from the University of Missouri-Columbia. Formerly, this expert served as a Team Leader at the U.S. Food and Drug Administration, as a Principal Consultant at Parexel,...
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An FDA Regulations expert witness provides insight on compliance, regulatory standards, and industry practices. They can testify on violations, product safety, and approval processes.
Cases involving pharmaceuticals, medical devices, food safety, dietary supplements, cosmetics, or any product regulated by the FDA may require such an expert witness.
Yes. These experts can provide valuable insights into the complex process of drug approval and how deviations from this process can lead to legal issues.
Yes. Subspecialties can include pharmaceutical regulations, food safety standards, medical device regulations, cosmetic regulations, and more.
They can evaluate whether the manufacturer complied with FDA regulations regarding reporting adverse events and if failure to comply contributed to harm.
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