We have a experienced, dedicated global regulatory affairs service team who provides CMC services for global customers in the Drug's whole lifecycle , including Investigational New Drug Application (IND/CTA), New Drug Application (NDA/MAA) and Abbreviated New Drug Application (ANDA), post-approval regulatory services such as variation, annual report and re-registration etc. 

Our team members are highly experienced in domestic and international registration and CMC filing. And as a DMF Holder, we has experienced successfully in CMC filing for several APIs in major regulatory bodies, such as US, Europe (EU/CEP), Canada, Japan, China, WHO and other markets, to get the confirmation or approval certificates.

Services scope:
* CMC R&D activities, providing synchronous assessment, plan and feasibility consultation 
* CMC manufacturing activities, providing regulatory compliance guidance and support 
* Filing preparation, compilation and technical review, ensure the quality of documents meet the submission requirements
* Drug applications (DMF, ASMF, CEP, MF, APIMF, API registration filing, etc.) in US, Europe, Japan, WHO, China and other countries 
* Chinese and/or English translation services for filing documents
* Good communication with authorities and timely feedback after submission