Never miss a regulatory change that affects your products
Alerts monitors international and national regulatory authorities around the clock, flags the guidance changes that apply to your product classes, and tells you what each one means in the markets where you sell.
Regulatory change, mapped to your portfolio
Every relevant update across authorities, tied to the products it affects. Explore the live workspace below.
The revised checklist adds notarized manufacturer declarations and a narrower window for deficiency responses.
RDC 612/2026 establishes an abbreviated registration route for biosimilars previously authorized by EMA, FDA, MHRA, or PMDA.
Nobody can read every authority's updates by hand
Guidance changes land across dozens of EMA and national-agency sources, in different formats and languages. Reading all of it is unrealistic; skimming it means missing the one update that affects your product. By the time a change surfaces internally, the deadline to act on it may already be close.
From the firehose to what actually affects you
We monitor every source
International and national authorities are tracked continuously: guidelines, Q&As, templates and procedural changes, as they're published.
We map it to your portfolio
Each change is matched against your products, classes and markets, so you only see what applies to you.
You get the impact and the action
A clear read on what changed, which of your MAs it touches and what to do next, ready to hand off into the work.
Signal, mapped to your products
Broad source coverage
EMA and national authorities monitored together, so no relevant change slips through a gap between sources.
Portfolio mapping
Every change tied to the specific products, classes and markets it affects, rather than a generic industry digest.
Localized impact
What a change means in each market, in plain terms, so you can judge urgency at a glance.
Straight into action
Hand a change off to obligation-to-action and Workbench to turn it into a product-specific to-do list.
The monitoring is done for you, mapped to your portfolio
Filtered against your portfolio
Everything that reaches you has already been matched to your products, so it's worth your attention.
Nothing slips
Continuous coverage across authorities means changes are caught early, with time to act.
Connected to the work
Alerts feeds Atlas and Workbench, so spotting a change and acting on it aren't separate tasks.
Regulatory monitoring that used to need a department — run by a team of a few.
See only the changes that matter to you
Book a demo and watch Alerts map regulatory change to your own products and markets.