Labelling Intelligence Platform
Move beyond basic compliance check-boxing. Give your regulatory affairs team the intelligence to defend bold claims, align global messaging, and maintain continuous market readiness.
The platform, at a glance
Your portfolio, its live findings and the authority sources behind them, on one screen.
One workspace for everything a label touches
Label documents, packaging files, promotional material, authority sources and competitor precedent in one place — kept under continuous active monitoring rather than filed away.
The day-to-day work, and the questions above it
Two of these clear your queue. Two of them change what you put on the label in the first place.
Global label & claim monitoring
Authority sources, reference products and your own portfolio watched continuously. Changes arrive as structured rules with the affected labels already identified.
Compliance gap analysis
Label documents, packaging files and leaflets checked against each market’s requirements and against each other — for meaning, not string match.
Competitive & precedence analysis
What has already been approved, and to whom. The evidence for writing a stronger claim — or the reason one was refused.
Ads & commercial material alignment
Promotional material read against the approved label and the local code — including the impression it leaves as a whole, not just the phrases in it.
Intelligence delivered right into your playground
Agents work inside the document your team already drafts in. Every suggestion carries the clause it came from, and you decide whether to take it.
Cardivastin is a selective, competitive inhibitor of HMG-CoA reductase.
In a randomized, double-blind placebo-controlled study, Cardivastin demonstrated a highly significant reduction in the risk of major cardiovascular events.
The treatment effect was consistent across all predefined subgroups, including patients with a history of type 2 diabetes.
Four stages, running on a loop
Nothing waits for a quarterly review. The cycle runs continuously and surfaces only what changed.
Bring it together
Label files, promotional material, and the authority sources that govern them.
Structure the rules
Regulations and guidance become atomic, checkable rules per market.
Compare and judge
Agents assess gaps, precedent and perception, and cite what they relied on.
Decide and record
Your reviewer accepts or overrules. The decision, and its reasoning, is logged.
Every finding is defensible in a room full of auditors
Deterministic orchestration, documented decision logic and source-traceable lineage — the output is evidence, not an opinion.
How our AI worksReproducible runs
Consistent, testable and validatable results on the same inputs.
Full audit trails
Output logs and documented evidence of conformity for every assessment.
Human decision points
Agents prepare the assessment; your regulatory reviewer still signs it.
Fits your stack
Runs as SaaS or as agents over MCP, alongside your DMS, RIM and QMS.
Authority sources, reference products and your own portfolio watched continuously. Changes arrive as structured rules with the affected labels already identified.
Test your most complex global label
Send us a core label document and its local packaging files. We’ll run a live gap analysis to show you exactly how the engine validates claims, spots precedence, and builds a defensible audit trail.