SciLucent’s staff includes scientific, medical, and regulatory professionals with expertise and experience in all aspects of healthcare product development and marketed product support.
Sabrina K. Sigua, RAC
Clinical Program Development and Implementation; Regulatory Strategy, Documentation, and Implementation; Labeling and Advertising
Sabrina Sigua specializes in providing strategic product development and regulatory guidance and preparing regulatory submissions and reports for the development of biologics and pharmaceuticals. Sabrina is experienced in providing regulatory strategy and support for the submission of BLAs and European Marketing Authorization Applications via mutual recognition in the Common Technical Document format; INDs, Amendments, and Annual Reports; BLAs and Supplements; NDAs and Supplements; and Safety Reports. She is knowledgeable about FDA labeling and advertising requirements. Her expertise includes vaccines, therapeutic proteins, and endocrine drugs.
