Alan P. Schwartz, EVP of mdi Consultants Inc. (Great Neck, NY), has been providing strategic planning on FDA regulatory compliance issues since 1978. Prior to mdi, Schwartz was a supervisor of field operations for the U.S. FDA. He has been an invited speaker on FDA policy and issues both in the United States and internationally. His insight and understanding of FDA regulatory strategy, preparation of replies to FDA 483 and warning letters, and acting as a third-party certification under FDA approval has provided companies with some very novel approaches to dealing with their regulatory problems and ensuring full compliance.