How to prepare early for regulatory submissions from IND to BLA

Early Preparation for IND and BLA Submissions. Illustration of the phases of vaccine clinical trials, showing a progression from preclinical research to Phase 1, Phase 2, Phase 3, and regulatory approval, with icons representing laboratory testing, small and large groups of participants, and final distribution.

Early Preparation for IND and BLA Submissions Bringing a new cell and gene therapy (CGT) to market is a complex journey, and one that requires rigorous testing and adherence to safety and regulatory standards. At BioLife Solutions, we have supported many drug manufacturers as they prepare for Investigational New Drug (IND) and Biologics License Application […]

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