Ernest A. Carabillo, Jr.
FDA Regulatory Planning
Mr. Carabillo is an internationally recognized authority on regulatory affairs and clinical and quality management issues. Previously he was the founder and president of EXPERTech, a renowned FDA regulatory consulting group, and was Vice President of Corporate Regulatory and Quality Administration for Baxter Healthcare Corporation. Prior to that, he was the management board member responsible for those activities at Dade Diagnostics, C.R. Bard's Implant and Critical Care divisions, and the Medical Device and Pharmaceutical Divisions of Union Carbide. In government, he served as the Associate Director for Regulatory Affairs of the office of Drug Abuse Policy in the executive office of the President, prior to which he held positions in the Department of Justice (DEA) and the Food and Drug Administration, serving as the Chief of three divisions. He is admitted to the Supreme Court of the United States, and the New York State Bar. He is also a Pharmacist. |