• Scientific Advice

• Product information

  • Preparation of product information
  • Bridging Report
  • Package Leaflet readability test
  • Translation of Patient Information

• Dossier preparation

  • Medical writing - preparation of registration dossier
  • CTD Module 3 - Quality
  • Product information
  • Enviromental Risk Assessment (ERA)

MA Handling

• Handling of the registration process

Post-authorisation

• Post-authorisation procedures support
• Product lifecycle management
• Sunset clause
• OTC switch
• Transfer of MA
• Medical Information