Lee Leichter RAC, MBA P/L Biomedical

Lee Leichter RAC, MBA

Lee Leichter RAC, MBA P/L Biomedical President

Lee Leichter has close to 50 years’ experience in the health care industry, providing direct, hands-on assistance to domestic and international Pharmaceutical, Biotechnology and Medical Device companies for the last 30. Projects have encompassed a multitude of business, technical, regulatory and quality issues, primarily related to drug delivery and combination products for marketing in the USA, Europe and Canada. He has worked with large multi-national companies, as well as start-ups, successfully navigating the challenges posed during the development, testing and marketing approval of products that merge pharmaceutical substances with high-tech device systems. He has been a subject matter expert working with the ISO and AAMI committees on drug delivery devices and Combination products, and convenor for the just published ISO On-Body Delivery Systems Standard. He is currently the PDA IG Leader for Combination Products.