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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.
Joshua Sharlin, Ph.D. is an FDA regulatory expert witness and compliance consultant with extensive experience in the pharmaceutical and medical device industries. Here are some key details about Dr. Sharlin:
Background and Expertise
Dr. Sharlin holds a Ph.D. in Physiology from the University of Georgia.47 He is the Principal Consultant at Sharlin Consulting, LLC, where he provides FDA regulatory expertise and expert witness services.67
Professional Experience
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Former FDA Drug Reviewer: Dr. Sharlin previously worked as a drug reviewer at the Food and Drug Administration (FDA).34
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Extensive Consulting Experience: He has over 25 years of experience as an FDA compliance consultant.3
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Expert Witness: Dr. Sharlin has served as an FDA regulatory expert witness for 10+ years, participating in over 50 cases.56
Areas of Expertise
Dr. Sharlin specializes in:
- FDA regulations and compliance
- Drug and medical device safety
- Biological sciences and statistics
- Software development and data integrity
- Technical writing and education on FDA-related topics12
Notable Achievements
- Trained over 50,000 people from FDA-regulated companies on regulatory topics.13
- Developed and presented more than 40 FDA-related technical and compliance classes.3
- Skilled at explaining complex FDA-related information to judges and juries.1
Expert Witness Work
Dr. Sharlin has provided expert testimony in cases involving:
- Death or injury caused by drugs, biologics, or medical devices
- Patent disputes
- Insurance claims
- Wrongful termination
- Trade secrets
- Product labeling
- Mergers and acquisitions15
His experience includes 50 cases, 22 expert reports, 15 depositions, and 3 testimonies. He has never been successfully Daubert challenged.6
