SERVICES

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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

  • Type-1 use
  • Type-2 use
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