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FDA 505(b)(2) NDA Got Approval

Case Six

FDA 505(b)(2) NDA Got Approval

KRB RA team provided consulting services for a domestic company's NDA application for sustained release microspheres in US FDA, which included R&D protocols and data review, project strategy formulation, project management, multi-round rolling review for CMC documents, NDA package preparation, translation, submission and following up. Via the joint efforts of the client and our team, we finally obtained FDA approval as expected.

CASES SHOW

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.

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.

Class 5.2 Imported OSD Got NMPA Approval

KRB RA team supported for an overseas company to launch their Oral Solid Dosage Form (OSD) 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, protocols & studies& reports communication and control for the BE CRO, professional document translation, ANDA 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 EU marketed product but with only feeding studies while the fasting studies were carried out in China to support for China submission, finally we successfully helped the client to obtain the Drug Registration Certificate.

Class 1 Innovative Drug Got NMPA Phase III IND Approval

KRB RA team provided consulting services for a domestic company's IND application for an innovative injection against China NMPA with overseas Phase I and Phase II data, which includes R&D protocols and data review, project strategy formulation, project management and supervision of CDMO & non-clinical lab, CDE Pre-IND meeting, multi-round rolling review for CMC and non-clinical documents, IND package preparation, submission and following up. This project is a license-in product with overseas phase I and phase II data contracted to a domestic CDMO for production, via the joint efforts of the client and our team, we finally obtained IND approval for Phase III as expected.

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