Sharlin Consulting, LLC

Joshua Sharlin, Ph.D.

Expert Witness: FDA Regulations
FDA Regulatory Consultant (25 Years)
Expert Witness (10 Years)


Dr. Sharlin delivered authoritative testimony to a jury regarding the nuances of FDA’s drug approval process. Josh was thorough and effective in countering opposing counsel’s arguments.

Shawn F. Brousseau 
Napierski, VanDenburgh, Napierski & O’Connor, LLP
Albany, NY

Dr. Sharlin provided skilled answers during a deposition involving patient safety compliance. His clear responses and easy to understand reasoning provided strong and persuasive support for my case.

G. William Allen, Jr. Esq., 
Law Offices of G. William Allen, Jr.
Fort Lauderdale, FL 33316

Josh has conducted training classes for my company, FOI Services, Inc. for over 15 years. In that time, he has developed and taught over different 40 presentations on a wide variety of FDA-related regulatory and technical topics. His collective audience has been tens of thousands of participants from many hundreds of FDA regulated companies. His expertise spans drugs, biologics and medical devices, and he demonstrates an exceptional talent for synthesizing and explaining FDA-related concepts in an efficient, effective and accessible way that engages people both new to, and knowledgeable about, the topic at hand.

Marlene S. Bobka
FOI Services, Inc.
Clarksburg, MD

Josh has worked for me as an FDA compliance auditor for many years. One of his specialties is data integrity. He puts his experience as an FDA statistical reviewer and as the Director of Hotel Customer Information Systems for Marriott International to good use. His last two assignments involved companies that were near success in getting their drug approved, but auditors from FDA had detected serious data problems preventing approval. They called my company for help and I asked Josh to find a solution. Josh applied his considerable knowledge and experience about how clinical trial data are collected and analyzed and identified solutions that resolved FDA’s data objections for both companies. I count on him to find data integrity problems other auditors miss and remedy the ones that appear unsolvable.

Christopher Rush
FDA Quality and Regulatory Consultants (FDAQRC)
Cedar Park, TX

Dr. Sharlin assisted our firm in understanding key regulatory and scientific aspects of adverse event reporting in an opioid case. He described how FDA regulatory definitions and requirements affect the accuracy of information in adverse event databases and how the issue of causality creates a confounding factor.  Dr. Sharlin also identified inconsistencies in an opposing council’s expert report and explained how a person’s genome influences their opioid response. His broad knowledgebase was an important asset to our case.

Ernest W. Auciello, Jr.
Tucker Ellis, LLP
Cleveland, OH

Our firm was evaluating a case involving a child injured by an approved drug. We asked Dr. Sharlin to evaluate the timing of a warning which was placed on the drug’s label after the child was injured. We wanted to know, should the warning have been made sooner? Josh applied key insight about regulatory affairs to collect and evaluate adverse event information and create a timeline about what was known and when, about dangers using the drug. He investigated the scientific literature and acquired adverse event information from FDA through a Freedom of Information Act request. He also obtained useful feedback from senior FDA officials. Josh did a careful and thorough job. He presented options for next steps and gave us the information we needed to evaluate the case. Dr. Sharlin’s breadth of knowledge about regulatory affairs and his investigative abilities were invaluable.

Maryland Law Firm