Sugato De Parexel International

Sugato De is a Principal Consultant at PAREXEL Consulting with wide-ranging experience in the development and regulation of medical devices and in the creation and implementation of scientific and regulatory policy.  Mr. De has greater than 11 years of experience in the Center for Devices and Radiological Health (CDRH) at the FDA and has specialized expertise in the development of performance assessment methodologies for drug-delivery systems and in the development of clinical trials to establish the safety and efficacy of medical devices.  He also served as CDRH’s lead representative on the review of over 50 combination product reviews submitted via INDs, NDAs and BLAs and has comprehensive knowledge of regulatory strategies for the approval of these products.  As a Senior Policy Advisor in the Office of the Center Director, Mr. De was heavily involved in the development of new policy development for combination products.  Mr. De uses his extensive scientific, technical, device development and regulatory experience to assist clients in the development of nonclinical and clinical development plans and regulatory strategies with FDA to achieve their company objectives.