CORRECTIVE AND EVOLUTIONARY MAINTENANCE OF AN ECTD VIEWER

1. Installation and maintenance of an eCTD viewer at the Federal Agency for Medicines and Health Products and continuity in the versions installed at the FAMHP. 2. Installation and maintenance of new versions of the basic software (= evolutionary maintenance). 3. Migration of current data from the eCTD viewer to the new eCTD viewer of the new service provider. 4. Maintenance or custom development of an interface between the existing MPM application and the eCTD viewer. 5. Maintenance or custom development of an interface between the existing DTS application and the eCTD viewer. 6. Maintenance or custom development of an interface between the existing CESP of EMA application and the eCTD viewer. 7. Maintenance or custom development between the eCTD viewer and FAMHP systems to store all non-eCTD CESP submissions (i.e. NeeS, VNeeS, R&D-Clinical Trials). 8. Provide the option to manually download eCTD sequences. 9. Commercial and technical support during a period of 4 years. Definition of the SLAs governing this support. 10. Cost of licences for 200 users for a period of 4 years. 11. Installation and maintenance of the eCTD viewer in the FAMHP's UAT (User Acceptance Testing) environment. 12. Training session(s) if necessary for major releases of the new application.