Beth Silverstein

Beth has more than 25 years’ experience as a regulatory affairs professional, designing product development and regulatory strategies for pharmaceuticals, biologics, medical devices, and combination products and representing 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 prepared or 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 premarket approval PMA submissions for implantable devices. She has prepared several successful orphan drug designation requests and requests for accelerated approval. She is currently a Director of SciLucent, a firm providing regulatory and scientific consulting services to the biopharmaceutical industry. 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).