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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

NIH Funding Acknowledgment: Important Reminder – Please acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement.

PARTNERS

VersitiChildren's Hospital of WisconsinVA Medical CenterMarquette UniversityMSOEUWM