Fda Regulatory Expert Witnesses
Fda regulatory expert witnesses and consultants listed here may be able to form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts on fda regulatory. The fda regulatory expert witness listings on this page are typically from fields/areas of expertise such as: Medical Devices and Pharmaceutical Regulation.
Joshua Sharlin, PhD
SHARLIN CONSULTING
STEVENSVILLE, Maryland
Pharmaceutical Regulation, Medical Devices
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FDA, FDA Compliance, FDA Regulations, FDA MAUDE, FDA Drug Safety, FDA Warnings, FDA Drug Warnings, FDA Medical Device, FDA law, FDA regulatory, Drug Safety/FDA, FDA Medical Devices, Biologics Safety FDA, Implant Safety/FDA, Medical device product liability
Worked as an FDA regulatory expert witness in over 50 cases, deposed 16 times and testified 5 times.
Based on experience training over 40,000 staff at FDA-regulated companies on technical and regulatory topics, skilled in explaining FDA related topics to juries.
Broad and deep skills in drug, biologic and medical device development. Hands-on experience in the entire lifecycle of product development from initial regulatory strategy, clinical trial planning and execution, to submission preparation and review at FDA. Authority in the collection, statistical analysis, interpretation, and presentation of information to FDA. Expert in understanding FDA reviewer’s actions and reactions.
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?
Provide FDA related ...
