Michal Aviv, Ph.D

Quality & Regulatory Project Manager

Michal holds a Ph.D. and M.S.c in life science from the Hebrew University.

Michal has an extensive regulatory expertise in medical device and drug development throughout all stages of development. Prior to joining Gsap, Michal held regulatory positions in Teva, Protalilx, KAMADA and Philips, where she managed regulatory teams and led and supported global regulatory submissions

Medical device projects: formulating global regulatory strategies for medical device projects from development to life cycle, management and preparation of regulatory submissions (e.g. 510(k), Technical Documentations, GSPR and China related documents), support of external audits (e.g. MDSAP, FDA, Notified Bodies).

Innovative small molecules and biological pharma projects: formulating global regulatory strategies from CMC, preclinical and clinical phases until approval and post approval phases, management and preparation of all aspects of regulatory submissions (e.g. FDA: preIND/NDA packages, INDs, PDP, ODD, FDA advisory Committee, NDA, sNDA; EMA: CTA, IMPD, Scientific Advise packages, PIP, MAA, variations; additional regulatory bodies), representation of the company’s regulatory approach with regulatory authorities.

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