Dossier Management and Assembly

  • A complete regulatory dossier management and assembly tool
  • Fully compliant with ICH and regional specifications, as well as electronic submission gateways
  • Easy way to build, view, publish and validate submissions based on standardised submission formats (eCTD, NeeS, Paper)
  • Including a built-in validator used by more than 35 regulatory authorities worldwide
  • Fast creation and sophisticated management of hyperlinks turning the collection of documents into a dossier where the information is linked
  • Pre-existing eCTD sequences smoothly imported into the system