Joshua Sharlin, Ph.D.

Expert Witness: FDA Regulations

Former FDA reviewer
Expert witness experience: Cases-37, Expert reports-16, Depositions-8, Testimony-1, Successful Daubert challenges-0
Experience: Regulatory consultant (25 years), expert witness (10 years)

My key skill is identifying and developing facts supporting your legal strategy

I am an FDA regulatory expert witness and an FDA compliance consultant skilled in the regulations and submissions of drugs, biologics and medical devices. In 2019, I completed a 3-year contract providing FDA regulatory advice to senior Army leadership in their pursuit of FDA approval for 15 products (drugs, vaccines, and medical devices) intended as defense against biological weapons.

I apply my broad and deep knowledge and experience as a biological scientist, statistician, software developer, data integrity specialist, technical writer, educator, and FDA regulatory expert to assemble what might appear to others to be unconnected facts and regulations, but what I use to create easy to understand opinions reinforcing your legal strategy.

My goal is bomb-proof opinions that checkmate the opposition.

Sharlin Consulting

Joshua Sharlin, PhD

jsharlin@pipeline.com

Cell: 410-231-8900

(Washington, D.C.)