About Joshua Sharlin, PhD
As an FDA expert witness, Dr. Sharlin is skillful at writing expert reports that describe and explain regulatory and compliance-related issues in cases involving FDA-regulated companies. Talented in depositions and testimony, his cases include medical devices, drugs, biologics. Issues include failure to warn, compliance with FDA regulations, drug & medical device approval process, labeling, complaint handling, and safety reporting. As a regulatory consultant, he applies his experience as an FDA drug reviewer and his hands-on proficiency in the entire life cycle of FDA drug and medical device approval process to identify and solve compliance and submission problems. His skills as a data integrity and software development expert were perfected while working as a programmer on the Consumer Price Index and as Director of Hotel Customer Information Systems for Marriott International. He has vast experience in Good Clinical Practice (GCP) auditing, software validation, Part 11 compliance, medical writing, SAS programming, regulatory strategy, preparing for FDA, and advisory committee meetings and answering reviewer questions. He is a skilled trainer, over 50,000 people have attended my training classes on over 40 FDA- related technical and regulatory topics.