Area of Expertise:
Sara Wong, MSc
Sara Wong is a clinical development and regulatory affairs professional, providing regulatory and technical support in the healthcare product industry. She assists in authoring clinical documents, such as Clinical Study Reports, Investigator Brochures, protocols, and electronic common technical document sections required for INDs and NDAs. She also processes, publishes, and performs quality control review of electronic regulatory submissions for filing to the U.S. Food and Drug Administration (FDA). Sara has prepared client-specific standard operating procedures according to regulations, guidelines, and appropriate stage of drug development. Sara has a B.S. in Human Ecology from the University of Texas and an MSc in Biomedical Engineering from Queen Mary University of London.