SciLucent’s staff includes scientific, medical, and regulatory professionals with expertise and experience in all aspects of healthcare product development and marketed product support.
Beth Silverstein, M.S., RAC
Clinical and Nonclinical Program Development and Implementation; Regulatory Strategy, Documentation, and Implementation; Marketed Product Support
Beth Silverstein is an experienced regulatory affairs professional with expertise in designing product development, preclinical/biocompatibility, clinical, and regulatory strategies for medical devices, pharmaceuticals, and dietary supplements. She has authored orphan drug designation requests to FDA and EMEA and has prepared regulatory submissions for medical devices (IDEs, 510(k)s, PMAs) and pharmaceuticals (INDs, NDAs). She represents U.S. and international clients in FDA product approval efforts. She is recognized for her experience in conducting due diligence assessments and critically assessing and qualifying in-licensing opportunities. She is expert in conducting safety and risk analyses of pharmaceutical excipients, biomaterials, cosmetic ingredients, dietary supplements, and food additives. Beth's expertise includes orthopedic, cardiovascular, neurologic, and plastic and reconstructive medical devices and cardiovascular, oncologic, immunologic, and endocrine drugs.
