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 © Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH