- Program Objective
- To minimize trial-and-error during the CMC preparation and to secure essential CMC data required for IND filing.
- Program Details
- Customized consulting and consulting-linked support through matching with a pool of designated service providers
- Program period: Up to 8 months per project
- Recruitment Period: Twice a year, scheduled between Q1 and Q3 each year
- Scope of support
Category
Description
Strategic
Development Consulting
- Review of candidate selection (including TPP, QTPP, CQA, etc.)
- Establishing development timelines and strategic plans from candidate selection to regulatory approval
Manufacturing and Production Consulting
- Optimization of large-scale manufacturing processes and formulation development
- Production of nonclinical/clinical materials and CDMO partnership management
Quality Evaluation Consulting
- Analytical method development, validation, and establishment of specifications and test procedures
- Interpretation of characterization results and development of remediation strategies
Regulatory Affairs and Inspection Consulting
- Preparation and authoring of CTD Module 3 (CMC)
- Establishment and implementation of GMP Quality systems
- IND submission and strategic liaison with regulatory authorities
Integrated CMC Consulting and Technical Support
- Sample manufacturing and analytical services in conjunction with CMC consulting
- Contact
CMC Support Team: kddf_cmc@kddf.org