Regulatory Information Management System · RIMS software
The RIMS built for intelligence
Connect product, registration and lifecycle data across your global portfolio on one unified model. freya.register brings external regulatory intelligence and Agent Workbench into the same picture, helping teams understand what changed, where it applies and what needs attention.
One product. Many records. What it takes to make them agree. Marketing film · 2:29 · muted loop, sound on click
One model, three industriesPharma & Biotech, Medical Devices, Consumer Health
Built by regulatory peopleFor regulatory people. 15+ years of expertise behind it.
AI-native by structureSME-curated structures on the DIA reference model
The disconnect Product, registration and lifecycle data across systems
Regulatory data still lives in too many places
Product, registration, lifecycle and obligation data sit across fragmented internal systems. The regulatory requirements and changes that govern them are tracked elsewhere, often in separate regulatory tracking software. When a question needs both, teams must first search, compare and reconcile information from multiple sources.
The information exists. The context has to be rebuilt every time.
freya.register connects the regulatory picture
One governed product master Maintain a consistent global product identity with controlled local variations.
Enter once. Reuse across the lifecycle. Carry product context into applications, registrations, obligations, structured data submissions and health authority interactions.
Assess change in portfolio context Connect external regulatory change with the products, markets and registrations it may affect, while keeping regulatory experts in control.
Day-to-day impactSix jobs across one working week
Where disconnected data slows the work
The six jobs, before and after
Assess a change once Lifecycle management
Today. A site change arrives and becomes one mail thread per affiliate. Three weeks later you have three different answers and no list.
With freya.register. Read against the product master and resolved to every affected registration in one pass: one list, one assessment, one owner.
Stop re-entering the same product Product master
Today. The same product is keyed into the registration system, the dossier, the submission tracker and the affiliate spreadsheet. Each copy drifts.
With freya.register. Entered once on the product master and inherited by every application, registration and data submission. Every downstream record stays in step with it.
See what expires before it expires Registrations
Today. Renewals live in a tracker someone has to remember to update, and the first signal is often the health authority.
With freya.register. Renewal dates and expiry triggers driven by the registrations you actually hold, surfaced against the record itself.
One answer when commercial asks Registrations
Today. "Can we ship this in Brazil?" takes two days and comes back differently from supply, commercial and regulatory.
With freya.register. Registration status, validity and selling status in a single view, with three teams reading the same line.
Expert time back on judgement Agentic layer
Today. SMEs spend the week reconciling spreadsheets and chasing status, and the judgement calls get whatever is left.
With freya.register. Expert hours go to the decisions only a person can make, which is where the gate sits anyway.
Structured submissions, one dataset Data submissions
Today. xEVMPD, IDMP, EUDAMED and UDI are each assembled from whatever source is nearest, so four schemes carry four versions of one product.
With freya.register. All four generated from the governed record, with scheme requirements handled per market.
One connected regulatory pictureInternal regulatory data · External regulatory intelligence · Agent Workbench
Ask it anything. Same picture answers.
External Regulatory IntelligenceMonitor › Map › Prioritise
Regulatory change, classified and prioritised against the registrations you actually hold.
Internal Regulatory DataEnter › Inherit › Govern
The governed system of record for your own portfolio. Enter once, reuse everywhere.
Agent WorkbenchIdentify › Assess › Recommend › Review
The Agentic Fleet, four live agents working across your own data and external regulatory intelligence together.
A regulatory expert reviews and decides Every output is decision support, reviewed by a regulatory user.
Illustrative sequence.
