The pharmaceutical and biotechnology landscape is evolving at a breakneck pace as the U.S. and ex-US marketplace move towards parity. Of particular interest is the Chinese market. Estimated to exceed $80Billion USD in 2008 this market is still showing double-digit growth. It is projected by 2015 China will represent the sixth largest pharmaceutical market in the world.

Pharmatech recognized the challenges of this maturing market. Though growing rapidly internally, the Chinese regulated life sciences market has yet to demonstrate an ability to participate competitively on the global playing field.

Participating successfully in a U.S.-Sino partnership, whether formal or project based requires several key elements to be successful. First, it is essential that you understand the customs of Chinese business in order to promote both understanding and cooperation. Second, establish a presence in China and develop strong relationships within the Chinese Government as they regulate the business environment. Lastly it is important to complement the indigenous expertise in China with a strong understanding of the development, compliance and business requirements necessary to compete in the global marketplace.

Pharmatech’s end-to-end expertise is unique in their ability to provide this comprehensive level of service to clients either looking to in-license products from China for the U.S. and European markets, or establish operations in China.

Case Study

Pharmatech has been chosen by the Pacific Biopharma group to develop the design for the first FDA and EMEA approved Chinese manufacturing facility for manufacturing biotechnology products for late stage clinical supplies in China. The project is a joint venture between the Pacific Biopharma Group headquartered in San Bruno, California and the China Medical City, based in Taizhou, PRC. The state-of-the-art manufacturing facility will be located in Taizhou, Jiangsu Province, in an emerging biomedical science park named China Medical City.

The facility will also be utilized for development projects borne at the California Institute for Quantitative Biosciences (QB3) whose lead campus is at the University of California, San Francisco as well as for developing new chemical entities through Phase III clinical trials. This will be the first of its kind of facility in China.

Pharmatech has taken a bold step forward to address the weakest link in the cGMP chain, the operator. Pharmatech’s operation in China, “Chamquest” has established the capability of providing the necessary expertise with individuals specifically trained in the nuances of U.S. cGMP’s, whether at the technical, management or shop-floor level. This is a tremendous advantage when preparing for a PAI. Pharmatech’s model and framework, coupled with depth of expertise and international experience provides the unique formula for establishing the first FDA approved manufacturing facility in China.