Class 5.1 Imported Injection Got NMPA Approval
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Class 5.1 Imported Injection Got NMPA Approval
KRB RA team supported for an overseas company to launch their injection with China NMPA which includes CTD dossier gap analysis, submission strategy development, project management, multiple rounds of guidance and review for the critical & major deficiencies recognized during gap analysis, professional document translation, NDA submission package preparation and submission, sample clearance and registration testing, CDE review following up, DL explanation and guidance for response, and DL response review following up until the final approval by China NMPA. This is an overseas marketed innovated product apply for NDA registration in China, we successfully helped the client to obtain local clinical trial exemption with overseas data so to enable NDA directly without local clinical trials, which was granted by NMPA and finally approved by NMPA.
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