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Joshua Sharlin, Ph.D.

Former FDA reviewer. FDA Expert Witness - cases with Drugs, Devices, Patents, Mergers, Business Interruption. Authority in Software, Data Integrity, Vaccine Compliance and GCP auditing.
Washington, District Of Columbia, United States
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Joshua Sharlin, Ph.D.

Former FDA reviewer. FDA Expert Witness - cases with Drugs, Devices, Patents, Mergers, Business Interruption. Authority in Software, Data Integrity, Vaccine Compliance and GCP auditing.
Washington, District Of Columbia, United States
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Dr. Joshua Sharlin is a highly-experienced regulatory compliance consultant and expert witness, specializing in Food and Drug Administration (FDA) related cases and compliance issues. With a strong background in data integrity and software development, he has provided support to attorneys in a wide range of cases, including death or injury caused by drugs or medical devices, patents, insurance claims, trade secrets, mergers and acquisitions, and wrongful termination.

Dr. Sharlin has expertise in the entire lifecycle of FDA-regulated product development, from developing an initial regulatory strategy to review and approval at FDA. He is highly skilled in analyzing FDA compliance information to provide guidance on three key questions: what the company knew and when it knew it, what the company should have known and when it should have known it, and what the company should have done and when it should have done it.

In addition to his work with the legal profession, Dr. Sharlin has also supported the Department of Defense in FDA compliance of medical countermeasures development, with a particular focus on vaccine development. His hands-on experience, combined with his ability to write expert reports and provide testimony, make him a valuable asset to any team in need of FDA regulatory compliance expertise.

Dr. Sharlin obtained his education from the University of Iowa, the University of Maryland College Park, and The University of Georgia. He is currently the Principal Consultant at Dr. Sharlin's Recent Expert Witness Work, having previously held the role of Principal Consultant at Sharlin Consulting. Prior to his work as a consultant, Dr. Sharlin was a Drug Reviewer at the FDA and served as Director of Hotel Customer Information Systems at Marriott International, where he managed a software development team.

This public profile is provided courtesy of Clay. All information found here is in the public domain.