Compilation of Registration Documentation

  • Compilation and preparation of registration dossiers in CTD-Format (eCTD in preparation)
  • Quality documentation
  • Non-clinical documentation
  • Clinical documentation
  • Composing of overviews und summaries on quality, safety and efficacy
  • Compilation of obligatory texts (SPC, PIL, labelling) in compliance with national legal requirements
  • Composing of biowaivers
  • Consultations with target patient groups for the package leaflet
  • Switch of dossiers into CTD-format
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