Alan Donald is currently President, CEO, and Founder of Matrix, a consulting firm specializing in domestic, Food and Drug Administration (FDA), and international regulations related to medical devices, biologics, and pharmaceuticals. Prior to Matrix, Donald was president, CEO, and founder of Pacific Regulatory Services, Inc. (PRSI), a consulting firm specializing in FDA regulation of devices, biologics and drugs; product development, and quality assurance.

As Director of Regulatory Affairs for ABA, Donald worked on regulatory affairs including domestic and international projects in technologies and products ranging from breast implants to AIDS therapies. Donald was the Senior Manager of Regulatory Affairs and Quality Assurance specializing in human skin grown synthetically for human transplants. There he directed corporate-wide regulatory and quality assurance programs in compliance with FDA regulations. As V.P. of Operations, Donald was responsible for production, quality control, and regulatory affairs at Tri-Stage, a manufacturer and marketer of dental implants and associated instruments. The company was acquired by Collagen Corporation in November, 1989 for cash and royalty payments. Donald was retained by Collagen to facilitate the transfer for products and technology. While at Windsor Medical he managed eight departments, significantly reducing operational/manufacturing costs while increasing product quality and reliability. The company specialized in portable, programmable insulin infusion pumps and other diabetic therapy-related products. The company was sold to C.R. Bard. Donald held various management positions at IMED, a manufacturer of intravenous therapy products.

Alan Donald received his MA in Biochemistry from San Diego State University and performed specialty studies at Harvard University. He received his Executive MBA from University of California.

Donald’s additional contributions include: Member, Tech Coast Angels; Member, ASTM Standards Group for Tissue-Engineered Medical Products; Regulatory Affairs Professional Society; The Honorable Mark Wyland Biologics Advisory Committee; Professor, Regulatory Affairs, Master’s Program, Center for Bio / Pharmaceutical and Biodevice Development, San Diego State University; Lead Auditor, Registrar’s Accreditation Board; National Institutes of Health (NIH); Small Business Innovation Research (SBIR) Grant Review Committee; National Institute on Drugs of Abuse (NIDA); Member, BIOCOM; Medical Device and Diagnostic Industry (MD&DI) Technical Advisory Board.

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