Global RA Program
- Program Objective
- To support projects working on KDDF Program in preparing and submitting Investigational New Drug (IND) applications to the U.S. FDA.
- Program Details
- Program period: Apr-Nov, 2026
- Scope of Support
① Pre-IND Meeting Support
- Assistance with submitting Pre-IND meeting requests in accordance with FDA guidelines.
- Review and submission of meeting briefing materials.
- Facilitation of Pre-IND meetings in collaboration with U.S.-based CROs.
② IND Filing and Management Support
- Preparation and management of all required IND submission documents.
- Review of Investigator's Brochure (IB) and related documentation.
- Submission of IND applications in eCTD format.
③ Additional Consulting
- Advisory support for early-phase study protocols and synopses.
- Gap analysis and strategic consulting.
④ Guidance on pre-IND and NDA preparation and overall regulatory readiness.
- Contact
R&D Enabling & Strategy Team: rnd_project@kddf.org