Mr. Aleman began his career with the FDA as an investigator in Dallas, Texas in 1972. He has more than 25 years Supervisory/Management experience in the regulatory and enforcement area, primarily dealing with compliance issues confronting the drug, biologic, medical device, and dietary supplement industries regarding FDA and international requirements and regulations. Twenty-Eight (28) years of FDA experience in both the field and headquarters organizations, specializing in biopharmaceuticals, drugs and medical devices, including serving as the Biologics Specialist at the FDA’s Miami Resident Post. He is bilingual with extensive international experience in assessing API, drug product, small molecule and biopharmaceutical products. He has provided expertise to the US AID, World Health Organization (WHO), the Food and Agricultural Organization of the United Nations (FAO), and United States Pharmacopeia (USP) and has served as FDA representative at international conferences in El Salvador, Venezuela, Guatemala, Philippine Islands, Canada, Argentina, Brazil, Mexico, and the Commonwealth of the Northern Marina Islands (CNMI). In addition to his FDA experience, Mr. Aleman has served as Consultant and Lead Auditor to USP for four years.
Mr. Aleman is a graduate of St. Mary’s University, San Antonio, TX with a major in Biology and a minor in Chemistry.