Pharmatech Conference Returns to Shanghai to Advise Chinese Firms on SFDA Regulatory Guidelines
HAYWARD, Calif.--(BUSINESS WIRE)--Dec 8, 2009 - Pharmatech Associates, consultants to the pharmaceutical, biotech and other regulated life sciences industries, is returning to Shanghai this week to host a new two-day conference for companies working in biotech, biomedical, bio pharma, and other regulated areas of the biological sciences. The conference (Dec 11-12) will focus on fundamental quality activities such as Root Cause Analysis (RCA) and Corrective Action / Preventive Action (CAPA) to help corporations achieve compliance with the new regulatory guidelines issued by the People's Republic of China's State Food and Drug Administration (SFDA). Attendees will learn about compliance with SFDA guidelines and their correlation with FDA / EMEA requirements in the United States and the European Union.
Well-versed in international facility and process compliance, Pharmatech's chief expertise is navigating the complexities of the product development lifecycle in the biosciences industry. In China, Pharmatech has had a high-profile role in providing the Basis of Design for the first FDA- and EMEA-approved biomanufacturing facility in Taizhou. The company counsels firms in North America, Europe, and Asia.
“As China intensifies supervision on the production and quality of essential drugs, Pharmatech continues to receive inquiries from Chinese biosciences companies about compliance with the SFDA's new guidelines,” said Bikash Chatterjee, President and CTO of Pharmatech Associates, and one of the conference's featured speakers. “Our experience with product development and regulatory agencies worldwide means we can offer insight on how to establish robust, reproducible quality standards in accordance with international guidance. With the success of our initial workshops, we realize the extent to which Chinese bioscience companies are avid to get on board.”
About Pharmatech Associates
Pharmatech Associates, Inc. (founded 1995) consults to the pharmaceutical, biotech, medical device manufacturing and other regulated life sciences industries. Headquartered in the San Francisco Bay Area, Pharmatech advises clients that range in size from startups to large multi-national corporations on projects in North America, Asia, and Europe. Please visit: www.pharmatechassociates.com
Posted: December 2009