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IND/IDE and Regulatory Affairs Services

CRQ offers IND/IDE and Regulatory Affairs Services for supporting clinical research on FDA regulated products at Stanford University. We provide IND/IDE sponsors, investigators, and research staff with regulatory guidance along with tools and templates to support the research team navigate through the regulatory environment for conducting clinical research.

Contact CRQ IND/IDE and Regulatory Affairs Services for consultation on:

  • FDA pre-submission and meetings (Q-subs)
  • Original INDs, IDEs, amendments, supplements, notices & reports
  • IND/IDE transfers
  • GMPs and QSRs
  • Expanded Access
     

Other Regulatory Resources