Shawn F. Brousseau
Napierski, VanDenburgh, Napierski & O’Connor, LLP
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.
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
Maryland Law Firm