Beth Silverstein, MS, RAC-US

Beth is an experienced regulatory affairs professional, with more than 25 years’ experience designing product development and regulatory strategies for pharmaceuticals, biologics, medical devices, and combination products. She provides regulatory representation to U.S. and international clients in FDA product approval efforts. Her broad expertise also includes the development of dietary supplements and cosmetic ingredients. She has drafted, compiled, and managed the preparation of INDs, NDAs, Annual Reports, Investigator Brochures, and Safety Reports for drug and combination products. She has prepared and successfully filed regulatory submissions for medical devices, including 510(k)s, IDEs for significant risk devices, and pre- and postmarket approval submissions for implantable devices. She has experience with the use of in vitro diagnostic devices in drug trials. Beth has prepared and submitted many successful orphan drug designation requests and requests for accelerated approval and priority review. Beth has an M.S. in Zoology (Physiology) from The Ohio State University and a B.S. in Biology from Binghamton University. She maintains Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS).