Under the agreement, Pharmatech will use all its expertise and experience in regulatory affairs to help the Chinese manufacturer to meet the required compliance demanded by the regulatory agencies in China and the US (sFDA and FDA).
The new Guangdong project will begin in July and is expected to last 18 months, reaching completion by the end of 2012.
Pharmatech chairman and CEO Calvin Wong said they 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.
Pharmatech president and CTO Bikash Chatterjee said their 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.