Procurement of a SaaS solution to handle dossiers connected to applications for marketing licences for medicines - eSubmissions.

The overall aim of the procurement is to solve the Norwegian Medicines Agency's (NOMA) need for eSubmission management. The procurement is connected to the ongoing process of modernising NOMA's case management systems. The modernisation has uncovered a need to reduce manual work connected to handling the reception, making available, and journaling of dossiers that are submitted for applications for marketing licences (MT) for case management. The existing systems are difficult to continue without a large part of the manual work be transferred from the archive function to executive employees. By introducing a system that both handles loading, validating, and making dossiers available, and which can be integrated with the next generation case management system in NOMA, this problem will be solved:

- To automise the process of receiving, validating, and making dossiers available that are received from CESP, Common Repository, and in the future DADI / PL

- Lay the basis for being able to automise corrections and updates to cases in NOMA's new case management system, DELE

- To facilitate NOMA's executive employees having a suitable and user friendly tool for insight in and processing of all relevant dossiers

- To facilitate the use of eCTD version 4.0