Joshua Sharlin, Ph.D.

Joshua Sharlin, Ph.D. is an FDA regulatory expert specializing in pharmaceutical regulation, medical devices, and drug development. With extensive experience in drug, biologic, and medical device development, he brings a comprehensive understanding of FDA regulatory strategy and clinical trial planning to litigation work. His work centers on investigating FDA compliance, assessing regulatory submissions, and evaluating whether companies met FDA standards.

Dr. Sharlin has been retained in numerous expert witness and consulting engagements across the United States, involving cases such as drug safety, medical device product liability, and FDA compliance. His Ph.D. in Physiology, along with his extensive experience as a former FDA reviewer, reinforce his ability to deliver objective, defensible analyses. He is regularly engaged by both plaintiff and defense counsel to provide clear, independent determinations of regulatory compliance and responsibility in disputes involving FDA-related matters.