Jamie Jamshidi, Biotech-Pharmaceutical Quality & Regulatory Advisor has over 27 years of industry experience, including small molecules and large molecule biologicals.

Jamie has a broad understanding of the entire drug development process for both large molecule proteins and small molecules. She has extensive knowledge of U.S. Regulatory Filings through product life cycle, FDA Current Good Manufacturing Practices (CGMP), Current Good Laboratory Practices (CGLP) and Current Good Clinical Practices (CGCP), European and Japanese drug manufacturing regulations, ICH guidelines, and Qualified Person (QP) requirements under EU Directives, and World Health Organization (WHO) regulations.

Jamie also has extensive experience in the development and commercialization of pharmaceuticals and biotechnology at all process stages, including Drug Substance (API), Drug Product, Packaging, and Labeling. She has given numerous lectures and talks in the areas of Quality and Regulatory in several colleges, universities and conferences globally. She is well known in bio/pharmaceutical industry for her passion and respect for laws and regulations in ensuring product quality.