Pharmatech Associates Selected by Leading Chinese Pharmaceutical Manufacturer for Facility Design and Compliance
HAYWARD, Calif.--(BUSINESS WIRE)--Pharmatech Associates, a compliance consulting firm serving companies in the pharmaceutical, biotech and medical device industries, will provide design and compliance review and guidance for a leading Chinese pharmaceutical corporation's aseptic product manufacturing facility in Guangdong province. The Chinese firm tapped Pharmatech Associates for its detailed understanding of the technical and compliance requirements of processes and facilities from among a half-dozen consulting firms, including ones from China and Europe.
Pharmatech will lend its expertise and experience in global regulatory affairs to provide commissioning and validation services that ensure the new facility meets the compliance standards and guidance set by the regulatory agencies in China and the U.S. (sFDA and FDA). Previously, Pharmatech Associates undertook a high-profile role in providing the Basis of Design for a bio-manufacturing facility in Taizhou designed to meet FDA and EMEA compliance requirements. The new Guangdong project will begin in July and is expected to last 18 months, reaching completion by the end of 2012.
"We're very pleased for the opportunity to bring our fundamental quality expertise to China-a country now experiencing skyrocketing growth in the biosciences," said Calvin Wong, chairman and CEO of Pharmatech Associates. "As a global leader in compliance, we can help manufacturers in the pharmaceutical and regulated life sciences industry meet product safety requirements more quickly and effectively, enabling them to launch their products in a timely fashion. This is true whether the pharmaceutical manufacturing facility is located in North America, Europe, India, Japan or China."
"Our client considers its new facility in Guangdong vital to its success," said Bikash Chatterjee, president and CTO of Pharmatech Associates. "They've chosen to work with us because they can't afford delays to the development, approval and commercial launch of their products. Our compliance experts, former FDA compliance officers themselves, will also help train and prepare personnel for pre-approval inspections (PAI) so that operations run smoothly from day one."
About Pharmatech Associates
Pharmatech Associates, Inc. (founded in 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