Class 3.3 Therapeutic Biologics Got NMPA Phase I IND Approval
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Class 3.3 Therapeutic Biologics Got NMPA Phase I IND Approval
KRB RA team provided consulting services for a domestic company's IND application for an biological product with China NMPA, 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. Via the joint efforts of the client and our team, we finally obtained IND approval for Phase I as expected.
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