Laura Mondano is a Director in Voisin Consulting’s office in Cambridge, Massachusetts, USA. Laura assists clients in the design and implementation of global product development plans. She is involved in the development of Drug, Biologic, and Device products, including Cell and Tissue therapies.
Laura has extensive experience in interactions with the U. S. Food and Drug Administration, in particular in the preparation and coordination of Pre-IND/IDE meetings and the preparation of IND/IDE and product applications, including NDA (eCTD), BLA, PMA and 510(k) Notification.
Laura was Director, Global Regulatory Affairs at Genzyme Corporation in Cambridge, Massachusetts for more than 8 years. She led product development teams for Transplant and Haematology/Oncology Orphan Drug and Biologic therapies as well as Biosurgery, Cardiovascular, and Renal Cell/Tissue (including autologous and xenotransplant), Device and Combination therapies.
Prior to Genzyme, Laura spent more than 10 years in Regulatory/Clinical Affairs at large and small Device companies, including Boston Scientific Corporation and CR Bard, Inc., with a focus on Cardio/Peripheral Vascular, Orthopedic and Ophthalmic devices, including implants.
Laura earned a Bachelor of Science in Medical Technology at the University of New Hampshire in Durham, New Hampshire and has been certified by the American Society of Clinical Pathology (ASCP). Further studies in Mechanical Engineering Technology were undertaken at the University of Lowell, Massachusetts. Laura is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society (RAPS).
