SSR Supports

Ming Ye, M.D, Ph.D, is very experienced in assay development, clinical trials, safety assessments, and regulatory supports in both medical device and drug industry. As a medical graduate from Medical School of Fudan University, Dr. Ye practiced medicine for two years from 1991 to 1993. Thereafter, he was enrolled in a Ph.D. program at the Universit... y of Iowa. From there, he developed special interests in understanding pathways for bringing products from the lab bench to the FDA offices. After graduation, he joined Beckman Coulter, a global leader in diagnostic industry. He gained plethora of knowledge and hands-on experiences in product design and development, quality assurance and regulatory affairs for both IVD and non-IVD products. Later, he joined another medium-sized biopharmaceutical company. There, he fully contributed to clinical studies including clinical trial site opening, clinical lab data collection and analysis, and clinical trial report writing. He also provided support for drug safety assessment and documentation for regulatory submission and contributed to the cGMP compliance for the manufacturing facility. As the founder of the SSR Supports consulting service, Dr. Ye provides high quality services in device and drug development for FDA submission and in post-market safety surveillance.Read More