Service & Quality
Our analytical programs include API and drug product method development and validation and release, manufacturing support, IND and NDA enabling stability studies, reference standard qualification, impurity control, preformulation and product characterization. Our technical writers provide regulatory CMC support by composing IND and NDA packages, and have a proven record of successful submission of these packages to global regulatory agencies. Our commitment to world-class quality has been validated by government agencies as well as numerous clients, and we adhere to strict project and process management standards for all studies.
Based in Shanghai, China, the Analytical Service Unit has 8,500 square meters of laboratory space, with a capacity of approximately 1,000 cubic meters of available chamber storage. The facility houses state-of-the-art instruments to support analytical development and stability studies for both small and large molecule products.
Track Record of Success
From method development and validation to NDA preparation and submission, the Analytical Service Unit is your single solution for analytical development and regulatory support, having conducted stability programs for more than 2,000 batches of API and drug product and preparing over 50 CMC dossiers to date.