Common technical document (CTD)

  • Preparation of sections 2.4, 2.5, 2.6, 2.7, 4 and 5

Summary of Product Characteristics and Package Leaflet

  • Variations of the Summary of Product Characteristics and Package Leaflet according to Readability Guidelines

AIC renewal

  • Updating the dossier for the marketing authorization of the pharmaceutical product for safety and efficacy aspects

PSUR

  • Preparing the dossier