System for receiving, validation and reviewing marketing authorisation applications and other regulatory submissions for medicinal products

ns. 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 later. The procurement will also include the deployment, support and mai

ntenance services for the system to be procured. Life cycles of the medicinal product dossiers (sequences and attributes) must be migrated to the system. Migration will be part of the procurement. The purpose of this request for information