IND/IDE Consultation

IND/IDE Consultation

The CTO offers consultation services to Sponsor-Investigators for both Pre- IND calls with the FDA and preparation of Investigational New Drug (IND) / Investigational Device Exemption (IDE) submission packets. The staff also guides Sponsor-Investigators through various stages of application and provides documentation review and tools.

IND/IDE Application

The services include:

  • Facilitating communications with the US FDA
  • Scheduling and preparing for a Pre-IND Call
  • Provide tools and checklists for IND/IDE submission
  • Prepare and/or review the IND/IDE submission packet
  • Maintenance of an IND/IDE through the life of the study
  • Safety reporting and annual reporting to FDA
  • Prepare and support during an FDA inspection
  • Facilitate mock FDA inspections
  • Training Sponsor-Investigator and study staff on regulatory responsibilities for an IND/IDE study

To request our services, please complete and submit the Request a Consultation form through the link below.

Request a Consultation


VersitiChildren's Hospital of WisconsinVA Medical CenterMarquette UniversityMSOEUWM