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Solution & Service
Global CMC Filing

We have an experienced, dedicated global regulatory affairs service team that 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.

Services Scope

CMC R&D activities, providing synchronous assessment, plan and feasibility consultation, providing regulatory compliance guidance and support

CMC 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 the 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

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