• 乐发lll-追求健康,你我一起成长

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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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