Product Evaluation & Planning

• Due diligence
  • Evaluate prior development strategy
  • Evaluate existing data package
  • Prepare gap analysis
• Prepare regulatory and product development strategy
• Implement product development strategy
  • Undertake regulatory consultations
  • Plan development activities
  • Work with CROs and other third parties to implement the strategy
• Clinical pharmacology consultation
  • Ethnic sensitivity analysis
  • Bridging and planning for global clinical trials