About CELLX, INC
Yumpah provides strategic and tactical support for clinical development in cell and gene therapy, including regulatory submissions, FDA interactions, and manufacturing advice. The company focuses on accelerating programs to first-in-human clinical trials and ensuring compliance with FDA regulations.
Strategic and tactical support for clinical developmentRegulatory strategy development and indication prioritizationFDA submission assistance (IND, BLA, DMF, IDE, PMA)Expedited designation support (Fast Track, RMAT, BTD)Facility design and regulatory compliance supportManufacturing platform and process developmentAssay development, qualification, and validationCompliance with 21 CFR 200, 600, and 1271
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