James Stumpff

James "Jim" Stumpff is the President of James Stumpff & Associates, a consulting firm specializing in regulatory compliance and quality assurance for the medical device and biopharmaceutical industries. With over 30 years of combined experience in FDA and industry regulatory affairs, Jim has held key leadership roles, including Executive Director of Quality at Adamis/DMK Pharmaceuticals, where he oversaw Regulatory Affairs, Pharmacovigilance, and Quality Assurance. He also served as a Principal Consultant at Parexel International for nearly a decade, advising clients ranging from startups to global organizations.
 
Jim’s extensive career includes pivotal contributions during his time at the FDA, where he was involved in investigations of major industry scandals, such as the Generic Drug Scandals of the late 1980s and the landmark "Operation Goldpill" Medicaid fraud case. His work led to the development of critical FDA policies, including the pre-approval program and disbarment policy. A recognized thought leader, Jim frequently publishes industry articles and presents at conferences, helping shape regulatory practices and policies in the biopharmaceutical and medical device sectors.