Alan Donald

Mr. Donald has over 30 years of FDA and international regulatory/clinical experience in biomedical products including drugs, biologics, in vitro diagnostics, nutraceuticals, combination products, and medical devices across a wide diversity of therapeutic areas. In addition, he has advised financial groups when performing due diligence assessments of biomedical investment opportunities. He was a co-founder of two medical device companies. He is recognized as an expert witness in FDA compliance, product warnings, manufacturing practices, labeling, etc. in Federal and State courts. Since 2000, he has been an adjunct professor in the Master of Science in Regulatory Affairs program offered through the College of Sciences at San Diego State University. He is on (or has been on) the board of directors or advisory board of three medical firms and the San Diego Tech Coast Angels. After 18 years in the industry, Mr. Donald founded Matrix Medical Consulting, Inc., a business-focused regulatory and clinical consulting firm where he has advised some 75 domestic and international client companies on four continents. He has authored publications and made presentations at industry and legal conferences and workshops. Mr. Donald attended Harvard University and Claremont McKenna College, receiving a bachelor’s degree in biology/physiology. He later attended San Diego State University where he obtained a Masters’s degree in biochemistry/cell biology. In 1996, he obtained an executive MBA in high-tech businesses from the University of California. He is certified by the Regulatory Affairs Professionals Society RAPS) and was recognized as one of the RAPS's First Fellows in 2010.