- Chinese State Food Drug Administration, (SFDA) Regulatory Consultancy.
- In association with Chinese colleges, provide assistance for SFDA approval of the medical products in China.
- SFDA regulatory and compliance support for pharmaceutical, clinical diagnostic kit, medical device, nutraceutical and cosmetic products.
- Services include SFDA classification; feasibility analysis; regulatory filing; document translation; and response to SFDA.
Marketing and Distribution in China
- Screening and recruiting local medical product distributors and marketing companies, using well established strategic relationships with Chinese distributor network.
Contract Research Organization (CRO) Service in China
- Screening and recruiting high quality CRO service companies who can provide service match with FDA requirements.
- Services include: Active pharmaceutical ingredient (API) synthesis, animal safety test, CMS, Content Management System and clinical studies.
Chinese Clinical Education
- As a practicing Physician and Medical Director, acquire experience in clinical education in both USA and China.
- For each new medical product presented, coordinate the review with other physicians and experts to understand the product application and the medical problem it is intended to address.
- Organize medical conference and meeting with local Chinese doctors.
China Market Research
- Chinese business assessments through close relationships with clients, understand their business needs, and overall knowledge of the Chinese health products business and markets.
- In-depth marketing research in collaboration with local Chinese market research company to assess business opportunities and strategies.
- Provide detailed industrial reports on market segmentation, competition, price regulation and regulatory requirements.
Pharmaceutical Product and Biotechnology Licensing
- Fulfilling the needs of Chinese pharmaceutical and investing companies searching for new technology and business opportunity in U.S.A.
- Assistance to screen and recruit potential business partners and investors in China.
- In collaboration with Chinese attorneys, assist in filing patents in China to provide Chinese intellectual property protection.
Chinese product sourcing
- Assisting clients in locating medical product in China including APIs, medical device, Chinese herbs, nutraceutical and cosmetic products.
- Provide logistics, international shipment, and custom clearance for clients.
U.S. FDA regulatory consultancy
- Foreign client's registration of Active pharmaceutical ingredients (APIs), Chinese herbs and medical device through U.S. FDA.
- Logistics services in international shipment, and custom clearance in Los Angeles.
Undisclosed Company, Medical Director, 2009 - 2011
- Working with sales team, consulted and trained Chinese doctors for using human growth hormone.
- Organize and lead clinical research project related with growth hormone.
- Conduct phase II clinical study on PTH, in collaboration with Chinese FDA for regulations on clinical trials.
- Participate in identifying market opportunities and customer needs. Participate in designing new business plan.
- Organize medical research conference and meeting with key doctors for medical education.
Dragon Herbs Inc., Santa Monica, CA, Product Manager, 2007 - 2008
- Maintain a scientific database for support of global consumable product claims;
- Conduct safety analysis on imported Chinese herbs and other raw material according to FDA regulation. Sustain quality, safety and efficacy standards for all consumable products;
- Leading research and development project in nutritional supplement formulation.
- Training sales representatives in product related knowledge.
HNS International Inc., Tustin, CA, Medical Consultant, 2003 - 2007
- Identify market opportunity and potential customers for using needle free injector.
- Help company to find investor and business partner in China and Japan.
- Trained sales representatives in product related knowledge.
Chinese American Scientific Technology Assoc., Los Angeles, CA, Vice President, 2002 - 2004
- Organize biotech research conference and social network.
- In collaboration with Chinese local investors and Chinese pharmaceutical companies, established a platform for licensing new biotechnology, business investment.
Honors & Publications
Academic and Professional Affiliations
- Department of Urology, University of California Los Angeles (UCLA), Associate Researcher
- Division of Endocrinology, Mattel Children's Hospital, UCLA, Assistant Researcher, Associate Researcher
- Division of Endocrinology, Children's Hospital of Philadelphia, University of Pennsylvania, Postdoctoral Researcher
- Division of Endocrinology, Department of Medicine, University of Minnesota, Postdoctoral Researcher
- Endocrinology Research Institute, Tianjin Medical University, P. R. China, Attending Physician Department of Endocrinology, Tianjin Medical University Hospital, P. R. China, Resident
Publications and Patents
- Author and Co-Author of 17 publications-abstracts.
- U.S. Patent
- M.D. Medicine, Tianjin Medical University, Tianjin, China
- M.S. Molecular Biology, Tianjin Medical University, Tianjin, China