Sharlin Consulting, LLC

Joshua Sharlin, Ph.D.

Expert Witness: FDA Regulations
FDA 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. My experience includes 37 cases, 16 expert reports, and 8 depositions. I have never been successfully Daubert challenged.

I have broad and deep knowledge and experience as a biological scientist, statistician, software
developer, data integrity specialist, technical writer, educator, and FDA regulatory expert.

How does that benefit you? It means I can connect widely separated dots. What might appear
to others to be unrelated facts and regulations, I use to create easy to understand opinions reinforcing
your legal strategy.

My goal is bomb-proof opinions that will help checkmate opposing counsel.