Not only as a Contract Research Organization (CRO), but also a Contract Development and Manufacturing Organization (CDMO), ChemPartner began to offer pharmaceutical development and manufacturing services for small molecules and biologics in 2009.
Our Chemistry CMC team focuses on small molecule pharmaceutical development and manufacturing services, including process development, pre-formulation development, analytical method development and validation, and CTD support for regulatory filings . The team has knowledgeable senior leaders with multiple years of experience working in the pharmaceutical industry at the major US, European, and Japanese pharmaceutical companies. The expert staff includes more than 300 chemists (process, analytical, formulation), engineers, quality assurance, and plant operational and support staff.
The Biologics CMC team provides one-stop services for overall process development and IND application support. It has established complete quality system and complied with ICH guidelines and the highest standards of CFDA, FDA and EMA. It consists of over 100 experienced scientists with strong leadership, aiming to become the most reliable partner for customers on their way on new drug research and development. The leaders ensure that all projects undertaken by our teams are completed to regulatory requirements and our clients’ specifications.
ChemPartner is also constructing its GMP manufacturing site in Qidong, Jiangsu to meet various requirements for clients and expected to be completed in 2019.