PMDA Consultation
Regulatory Science Strategic / Comprehensive Consultation
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Development Strategy
- Environmental Analysis
- Market Analysis
- Gap Analysis
- Case-/Simulation-Study
- Feasibility Study
Orphan Drug Designation
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Clinical Trial Start-Up
- Drafting (Protocol・IB・ICF・SOP etc.)
- PMDA Consultation on Clinical Trial
- CTN Submission
- GCP Frameworks
- Trial Implementation
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Non-Clinical Study and CMC
- Data-Package Proposal
- Study Design
- GCTP/GMP Preliminary Inspection
- SOP Preparation
- Validation/Verification
Cartagena Application
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