• Guidance for pre-pre-IND INTERACT discussions with FDA
  • INTERACT meeting package preparation
  • Guidance for pre-IND discussions with FDA
  • Pre-IND meeting package preparation
  • Pre-clinical study design
  • Chemistry, Manufacturing and Controls (CMC) development
  • Initial Investigational New Drug (IND) preparation

Additionally, investigators may request support in the form of a Gap Analysis to shed light on what may be needed to support a successful IND application. The goal of this analysis is to improve understanding of how the data generated from the proof of concept, non-clinical studies, and the CMC section will 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 development and batch production records
  • Product cryopreservation / labeling / release / shipment
  • Technology transfer
  • Regulatory finalization and IND submission assistance
  • Phase I clinical development plan
  • FDA communications and commitments

Click on the link below if you would like to ask us about any of the regulatory services provided through the Initiative.

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