Services

Strategic planning

  • Clinical trial design
  • Regulatory strategy

Clinical trial execution

  • Protocol development
  • Site selection
  • Investigator meeting management
  • Site monitoring/management
  • Document management
  • Site monitoring
  • Biostatistics
  • Study report preparation

CMC strategy and formulation development

  • Formulation development – solution, suspension, emulsion, ointment and solid-dose
  • Manufacturing of materials for clinical trials
  • Selection of contract manufacturer
  • Manufacturing process transfer
  • Set-up of Quality Assurance procedures
  • Preparation for FDA inspections

Regulatory

  • Preparation and filing of FDA documents
    • IND
    • Orphan drug application
    • FDA briefing package
    • NDA