• Regulatory Roadmap
• Scientific Advice

• Product information

  • Preparation of product information
  • Package Leaflet readability test
  • Bridging Report
  • Translation of Patient Information
  • Product Information and mock-ups verification

• Dossier preparation

  • Medical writing - preparation of registration dossier
  • CTD Module 3 - Quality
  • Application Form preparation
  • Product information
  • Enviromental Risk Assessment (ERA)
  • Orphan Medicinal products
  • Preparation of the clinical part
• Dossier Gap Analysis

MA Handling

• Handling of the registration process
• eCTD compilation

Post-authorisation

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

• Regulatory consulting in the pharmaceutical industry
• MAH service