Alan Schwartz

Alan Schwartz, mdi Consultants, Inc., Great Neck, NY, has 39 years of FDA regulatory experience. He has been providing strategic planning on FDA regulatory compliance issues since 1978. Prior to mdi, Alan was a Supervisor of field operations for the US FDA. Mr. Schwartz has been an invited speaker on FDA policy and issues both in the US and internationally. He provides his expertise on the FDA to the medical device industry worldwide with clients in Japan, Korea, China, Taiwan, Germany, Italy, Argentina, Brazil and Canada. His experience in dealing with FDA inspections, prior to, during and after the FDA Investigator has left, is extensive having personally participated in over 400 FDA inspections. His insight and understanding of the FDA requirements, and providing a strategic plan in preparing replies to the 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. mdi has representatives in Korea, Israel, France, Russia and Czech. Mr. Schwartz is on the editorial advisory board of the xGMP.

Alan Schwartz
mdi Consultants, Inc.
55 Northern Blvd.
Great Neck, NY 11021

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