SciLucent’s staff includes scientific, medical, and regulatory professionals with expertise and experience in all aspects of healthcare product development and marketed product support.
Bonnie J. Sadow
Clinical Program Development and Implementation; Regulatory Strategy, Documentation, and Implementation
Bonnie Sadow specializes in providing strategic product development planning, regulatory guidance, and submission management for the development of biologics and pharmaceuticals. Bonnie is experienced in preparing INDs and BLAs. Bonnie also has substantial experience in providing regulatory oversight in conducting Phase I, II, and III clinical trials in the U.S. and Canada. She has represented sponsors at negotiation meetings with FDA and Health Canada. She is expert at the preparation of clinical study protocols, informed consent forms, clinical study reports, and investigator brochures for biologic and pharmaceutical products. Bonnie's expertise includes vaccines and therapeutic proteins.
