Orit Gamburg GSAP
Orit Gamburg GSAP RA & QA Consultant, Project Manager
My name is Orit Gamburg, I am B.Pharm, M.Sc., MBA, working as Regulatory Affairs & Quality Assurance Project Manager at GSAP since 2019, specializing in advanced therapies. With over 15 years of global experience, I provide regulatory and quality support for genetically modified cell-based therapies (CAR-T, TCR), autologous and allogeneic cell therapies, tissue-engineered products, extracellular vesicle-based therapies, and combination products. I have extensive expertise in regulatory strategy, IND submissions, GMP compliance, quality management systems, and preparations for regulatory inspections. I work with research institutes, hospitals, and biopharma companies worldwide, guiding them through clinical development and regulatory approval processes.