System for Management of Marketing Authorisation Tender

• Country: Finland
• Summary: System for Management of Marketing Authorisation Applications of Medicinal Products and Related Regulatory Submissions
• FIT Ref No: 141972460
• Deadline: 05 Jun 2026
• Financier: Self Financed
• Purchaser Ownership: Government
• Tender Value: Refer Document
• Notice Type: Tender
• Document Ref. No.: 612017
• Purchaser's Detail:
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• Description:
• The Finnish Medicines Agency Fimea (later Fimea) is preparing the procurement of a system for receiving and validation, as well as application management, document handling, archiving, and reviewing marketing authorisation 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 later. 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 modules instead. The procurement includes the following entities: - Marketing authorisation application management system as a software service including possibility to upscale and downscale number of users. - Implementation project, covering the delivery of the system and the deployment of the system and its continuous services, as well as user training. - Continuous services, including e.g. continuous support and maintenance services of the system to the agreed extent, to the extent that they are not included in the software service. - Complementary expert services, covering separately ordered expert work for tasks such as further development of the system, and change management including user training. - Possible options, ...
• Documents:

 Tender Notice