He has more than 20 years of experience in the world's top ten foreign pharmaceutical companies, and has served as the head of global registration affairs/head of registration affairs in Asia-Pacific. He has worked as vice president of a leading domestic listed group and is fully responsible for overseas registration projects. With many years of experience in corporate consulting, we provide customers with effective clinical research and development strategies and registration and marketing strategies.
Familiar with domestic and foreign registration regulations and guidelines, and is good at the formulation and implementation of registration strategies in the United States, Europe and Asia-Pacific region. We have rich practical experience in the regulatory requirements and registration strategies of chemical drugs, biological products, vaccines, generic drugs, biosimilar drugs, plant medicines (Chinese patent medicines) and medical devices in various countries and regions. The US FDA application program completed by the leadership team has more than 20 US IND applications in the past three years alone, many of which have obtained qualification certifications such as Fast Track, Breakthrough and Orphan Drug Designation; there is also a major application program for BLA to merge NDA.
He presides over on-site verification and certification from various advanced regulatory agencies (such as FDA, EMA, Singapore HSA), covering GMP, GCP, GDP and QMS verification, and has rich verification preparation and response experience.
Looking ahead, we will continue to strengthen technological innovation and service upgrading, promote the healthy development of the pharmaceutical industry, and create greater value for customers. We look forward to cooperating with global customers to create brilliance together.
Room 508, Building 8, Zhongke E-commerce Valley, No. 20 Guangde Street, Beijing Economic and Technological Development Area, Beijing City
+86 15001236015
Sophia.huang@brilliantmed.cn