Class 5.1 Imported Inhalation Got NMPA Approval

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Class 5.1 Imported Inhalation Got NMPA Approval

Class 5.1 Imported Inhalation Got NMPA Approval


KRB RA team supported for an overseas company to launch their inhalation 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 and also the client’s first product to submit China NDA, we successfully helped the client to obtain the Drug Registration Certificate.

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