EXTEDO’s Submission Management software tools are designed to meet the needs of both the pharmaceutical and crop industry. They cover all global standards like eCTD, NeeS or CADDY-xml. We provide safe and compliant submission and lifecycle management software, which is essential for your business success in the fast changing and highly regulated environment of these industries. All hubs provide you the greatest flexibility in designing your IT infrastructure on-premise or cloud based.
Build, view, validate and publish compliant submissions based on CTD, eCTD, NeeS, eCopy, IMPD, CTA, VNeeS, DMF, ASMF and other submission structures.
Reduce the complexity of viewing and reviewing archived and in-progress electronic submissions.
Manage the assembly and compilation of electronic dossiers within Crop Sciences. PlantOS supports the e-PRISM (USA), e-Index (CAN), CADDY-xml (EU) standards.
A complete eCTD and NeeS validation and reviewing solution used by over 35 authorities worldwide, including EMA.
Easily validate medicinal and veterinary electronic submissions with the validator that is used by over 35 authorities worldwide, including EMA.