Every guideline change, mapped to your MAs automatically
Regulatory change never stops. Regunaut connects continuous authority monitoring to your licence data, so each new guideline, Q&A or template update arrives already matched to the products it affects, with the impact spelled out.
A generic change becomes affected MAs
Revised ERA guideline
Generic agency update
Atorvastatin
Affected
Salbutamol
Affected
Metformin
Clear
Amoxicillin
Owner set
Outcome
4 products need attention
Regunaut turns a published update into a portfolio map: which products are touched, which are clear, and where action starts.
By the time a change reaches the right product owner, the clock is already running
Guidance shifts constantly across EMA and national agencies. Tracking it by hand is unrealistic, and even a spotted change still needs a separate, slow job to work out which of your products it touches. Impact gets assessed late or missed entirely, and deadlines arrive without warning.
From a published change to mapped portfolio impact
Alerts catches the change
International and national authorities are monitored continuously, so nothing relevant is published without you knowing.
It's matched to your portfolio
Each change is mapped against the products, classes and markets in Atlas, so a generic update becomes specific portfolio impact.
You see impact, ranked by urgency
A clear view of which MAs are affected and how soon you need to act, ready to hand off into the work that resolves it.
See exactly which MAs a new change affects
Alerts catches the change; Atlas and Workbench turn it into a product-specific impact map.
EMA revised the ERA guideline. Which of our MAs are affected, who owns the action, and what needs attention first?
Executive summary
The affected portfolio is smaller than the raw alert suggests. Four products touch the revised ERA guideline, but the active workstream is Atorvastatin plus Salbutamol.
Atorvastatin has a clear ERA gap. Salbutamol has a pending submission milestone where the change could matter. Metformin XR can be closed with owner acknowledgement, and the remaining product should stay visible as a low-priority watch item.
What the RA team gets is an impact map: not just 'there was a guideline update', but which MAs need work, who owns the next action, and what can be safely closed.
Portfolio impact map
Each recommendation carries its reasoning and a source trail, so the result can go straight to RA, BD or the product owner.
Review notes
Monitoring and portfolio context, in one loop
Nothing slips
Continuous coverage catches relevant changes early, with time to plan rather than react.
No manual cross-referencing
The map from change to affected MA is built for you instead of rebuilt by hand every time.
Impact you can act on
Each change comes with what it means for your products and what to do next.
Every change assessed while there is still time to act on it.
See portfolio impact the moment change lands
See how Regunaut maps every regulatory change to the products it affects.