The RIMS built for intelligence

A regulatory information management system, the category most people shorten to RIMS software. It holds product master data, applications, registrations, lifecycle obligations, structured data submissions and health-authority queries on one unified data model, with external regulatory intelligence mapped onto it and a live agent layer connected to both. It is part of Freya Fusion, Freyr's AI-first regulatory platform.

Yes, and we call it a working session because of how it runs. Ninety minutes on your own products, markets and use cases, with a Freyr regulatory practitioner alongside a solution architect, and a written summary of what we looked at afterwards. If you would rather start with a standard walkthrough, say so when you book and we will open with that.

Both descriptions are fair, and the distinction matters when you are shortlisting regulatory information management system software. On its own, freya.register is regulatory information management software: one system holding product, registration, lifecycle and submission data. It also sits on the freya fusion RIMS platform, which is what lets the same record serve external regulatory intelligence and the agent layer without an integration project. Buy it as regulatory operations software for one team, or adopt the platform and connect the rest over time. It is more than pharma regulatory software: the same model carries medical devices and consumer health.

Most often a spreadsheet estate, sometimes alongside regulatory tracking software that covers one part of the job. Teams commonly arrive with product registration tracking software holding the authorisations, separate regulatory submission management software for dossiers, and the relationships between them maintained by hand. The replacement is rarely all at once. Start with the product master and registrations, then bring lifecycle and submissions onto the same record as each one is ready.

Yes, by three routes used together. Agent-to-agent interoperability, so the Agentic Fleet works with the systems you already run. Freyr migration specialists, who do this as a standard part of every go-live. And API-based connectivity through open REST APIs to ERP, MDM, data lake, document and BI systems. A typical go-live is around eight months, data migration included.

Six, as at October 2026, in the Agent Workbench. For an internally triggered change or an external regulatory change, they work in sequence. PIA, Product Identification: which products a change touches. MIA, Market Identification: which markets and registrations it touches. VIA, Variation Identification: variation impact, filing type and documentation. RIA, Regulatory Impact Assessment: how a change reaches processes and products. CIA covers cosmetic ingredients and FIA covers food ingredients. Every output is decision support, reviewed by a regulatory user.

All three on one structure, with the interface adapting by product classification. IDMP / PMS, xEVMPD and eCTD for Pharmaceuticals & Biotech; UDI, GUDID and EUDAMED (EU MDR / IVDR) for Medical Devices; market notification schemes such as EU CPNP for Consumer Health.

Typically eight months from kick-off to go-live, including data migration, followed by a two-month hypercare period. Delivery is Agile with shorter sprint cycles, and the validation package is included: validation plan, IQ, OQ, UAT scripts, test reports and validation summary report.

No. Client data is not used to train third-party models. The agents work against your own governed record and Freyr's SME-curated regulatory dataset, on a multi-tenant platform with per-tenant database isolation.