Consultant Specializing in China Medical and Biotech Product Marketing and Distribution, SFDA and FDA Regulation, CRO Service, Product Sourcing and New Biotechnology Licensing

Technical Consultant #1827

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.

Languages

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