Area of Expertise:
Laura Mondano, B.S., RAC-US
Laura is a senior regulatory affairs professional with more than 25 years of experience supporting product development and regulatory approvals in the life sciences industry. Through interactions with FDA and a strong understanding of multidisciplinary operations, Laura helps clients manage risk throughout the regulatory process. Her vast experience includes developing regulatory strategies and drafting, compiling, and managing the preparation of regulatory submissions for U.S. biologics, pharmaceuticals, medical devices, and combination products. Laura also has experience with the Quality-CMC aspects of regulatory submissions involving cell therapies and combination products with medical devices. Laura has a bachelor’s degree in Medical Technology from the University of New Hampshire. She maintains her Regulatory Affairs Certification (RAC-US) from the Regulatory Affairs Professional Society (RAPS).