PACT-supported Regulatory Services

PACT is experienced in preparing INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) (formerly pre-pre-IND; pre-IND) meeting packets; original IND submissions and subsequent IND amendments and Chemistry, Manufacturing and Controls (CMC).

PACT can provide a gap anaylsis for investigators in need of insight as to adddional work that may be needed to support a successful IND application. The analysis will be geared toward an understanding of how the data generated from proof of concept, non-clinical and CMC development map to the requirements of an IND application. The gap analysis may cover the following areas, as needed:

  • Nonclinical studies to support the proposed clinical development plan
  • Manufacturing process for both nonclinical and clinical trial materials
  • Process development and scale up
  • Process validation
  • SOP develpment and batch production records
  • Product cryopreservation / labeling / release / shipment
  • Technology transfer
  • Regulatory finalization and IND submission assistance
  • Phase I and clinical develpment plan
  • FDA communications and commitments

Investigators also seeking to complete a PACT request for service application (RSA) for manufacturing or other translational services in parallel to regulatory services may also receive recommendations for facilitating a successful RSA as part of the gap analysis.

PACT 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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