Pharmaceutical Regulation Expert Witness Listings in Maryland

Welcome to our Pharmaceutical Regulation expert directory. Browse the profiles below to find the right expert witness in Pharmaceutical Regulation for your case. Our SEAK Expert Witness Database is always free to search.

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David B Ross, MD, PhD, MBI

Clarksville, Maryland
Pharmaceutical Regulation Expert Witness - Food and Drug Administration, Drug/Biologics Safety, Drug/Biologics Adverse Events, Drug/Biologics Labeling, Post-marketing Surveillance, Clinical Trials, FDA Regulations/Procedures, Investigational New Drug Applications(IND), New Drug Applications(NDA), Biologics Licensing Applications(BLA), GMPs, Compliance
I provide consulting services on legal issues in drug safety and efficacy. Specific focus areas include examining the adequacy of product labeling to inform health care providers and patients about the benefits and risks of drugs, biologics, and other FDA-regulated products, as well as the accuracy and completeness of information provided by pharmaceutical manufacturers to investors and securities regulators. My experience includes provision of expert input and support for research into the merits of an action, drafting of court filings, preparation of responses to opposing party filings, and conducting discovery. I have experience in preparing expert witness reports, depositions, and trial testimony. My professional background includes serving for 10 years with the FDA’s Center of Drug Evaluation and Review as a medical officer, senior medical reviewer, medical team leader, and drug review office management official. ➢ Ten years (1996-2006) at FDA Center for Drug Evaluation a...
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Joshua Sharlin, PhD Sharlin Consulting

Stevensville, Maryland
Medical Devices Expert Witness, Pharmaceutical Regulation Expert Witness - FDA, FDA Compliance, FDA Regulations, FDA Software, FDA Drug Safety, FDA Warnings, FDA Drug Warnings FDA Medical Device Safety, Hip Implant Safety/FDA, Medical Device Safety/FDA, Drug Safety/FDA, Labels/FDA, Biologics Safety FDA, Implant Safety/FDA, 510(k)/FDA, NDA/FDA, IND/FDA
Have provided Food and Drug Administration (FDA)-related regulatory support to attorneys in cases involving; (i) death or injury caused by drugs, biologics or medical devices, (ii) patents, (iii) insurance claims, (iv) wrongful termination, (v) trade secrets, (vi) merger and acquisitions. Expert in data integrity and software development. Talented in testimony and depositions. Hands-on experience in the entire lifecycle of FDA-regulated product development, from developing an initial regulatory strategy, thru data collection and analysis, to review and approval at FDA. Skilled at writing expert reports that describe and explain regulatory and compliance-related issues involving FDA-regulated companies. Specialist in analyzing FDA compliance information to answer three questions: 1) What did the company know and when did they know it? 2) What should the company have known and when should they have known it? 3) What should the company have done and when should they have done it? (Se...
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You can also find Pharmaceutical Regulation Expert Witnesses in:
Massachusetts, North Carolina, Texas, California, Arizona, Florida, and Maryland
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