IND Submission Assistance

The PACT Coordinating Center (CC) and PACT cell processing facilities (CPF) are experienced in preparing original IND submissions and subsequent IND amendments in compliance with the Code of Federal Regulations (Title 21 CFR 312). The PACT group can provide technical and administrative services to requesting investigators with IND applications and submissions. Periodic communications/meetings between a sponsor and FDA are conducted to resolve questions and issues prior to filing an IND, and occasionally throughout the course of a clinical investigation and product development as warranted by issues and events. PACT can assist investigators new to the IND submission process by navigating through and interpreting regulatory guidance documents in preparation of early stages of the IND application and provide consultation for and support with FDA interactions.

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