System for management of marketing authorisation applications of medicinal products and related regulatory submissions

on applications for medicinal products and related regulatory submissions. Fimea is primarily looking for a software as a service (SaaS) off-the shelf solution that is provided from a public cloud. The system shall enable the necessary integrations with Fimea's other systems, which will be defined l

ater. The aim of the market dialogue is to investigate the offerings of the different service providers; especially whether it is possible to acquire the planned system as a single integrated solution or is it necessary to procure separate