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Roy Feng-987dup

Dr. Rentian Feng

Executive Director, Clinical Service Center Inc., USA

Ph.D., the Chinese Academy of Medical Sciences; Master of the School of Pharmacy, Shandong University.
Over 20 years of work experience, respectively at the Chinese National Institutes for Food and Drug Control, domestic tertiary hospitals, and large pharmaceutical enterprises.

Extensive experience in basic medicine, clinical pharmacy, new drug and vaccine R&D, drug registration, and clinical trials. Possesses more than 10 years of team management experience.

Holds 13 years of experience working at NIH (National Institutes of Health, USA), CDC (Centers for Disease Control, USA) and some universities. Also, as the head of drug & vaccine QC, drug registration, and clinical trial departments, at several listed pharmaceutical companies and CROs.

Rich experience in U.S. drug registration submissions and clinical trials.

Holds a Regulatory Affairs Certificate from FDA and a Good Clinical Practice (GCP) certificate from the NIH Clinical Platform.

Capable of providing "One-stop" services for clients, from experimental protocol design for new drug safety assessment, report review, writing and submission of a complete IND application, organizing FDA IND Type B and Type C meetings, obtaining IND clinical approval, to initiating and completing clinical trials in the U.S.

Capable of providing "One-stop" services for clients, including experimental protocol design for new drug safety assessment, report review, writing and submission of a comprehensive IND application, organizing FDA IND Type B and Type C meetings, obtaining IND clinical approval, and to the initiation and completion of clinical trials in the U.S.