For RA/QA Teams
Take control of regulatory scope
before it starts to drift
As products, markets, and regulations evolve faster than existing structures can absorb.
Join Early Access
Early visibility into how the product takes shape
Opportunity to contribute expert RA/QA perspective
Be considered for early testing before release
The challenge
The reality regulatory teams recognise
Regulatory scope rarely breaks in a single moment. It erodes gradually through everyday work that, at the time, feels reasonable and necessary. Over time, scope becomes harder to explain, revisit, and defend, and applicability decisions start getting questioned — not because they were wrong, but because the context that justified them is no longer intact.
Evolving product scope without re-evaluated assumptions
Product scope evolves, while earlier regulatory assumptions remain anchored in outdated context
Incremental market expansion without a consolidated scope view
New markets and horizontal regulations are added incrementally, without a single controlled view of scope
Regulatory updates without sustained applicability follow-through
Regulatory updates are identified, but their impact on existing applicability decisions is not always assessed and carried forward consistently.
Fragmented applicability rationale
Applicability rationale becomes distributed across documents, tools, and individuals.
Why this has become a governance issue
The issue is no longer expertise, but continuity. As regulatory scope must remain continuously current and defensible, document-centric structures lead to reactive reconstruction — exposing scope instead of governing it.
Our approach
What we are building
Compliance Studio is not just a tool. It is a new infrastructure for regulatory control.
Work from a globally curated and validated corpus of regulations, guidances, and standards — not fragmented sources
Maintain clarity across products and markets through structure based on product types, markets, and regulatory relationships
Keep applicability decisions alive as products, markets, and regulations evolve
Treat Applicable Lists as a living, traceable representation of regulatory scope — not static documents reconstructed under pressure
How this works in practice
Update monitoring
Every regulation in your Applicable List is monitored continuously. When something changes, you are not simply notified — the update is delivered in the exact product and market context where it matters, anchored to your existing regulatory reasoning.
AI-assisted understanding, under governance
Specialised AI agents for legislation, guidances, and standards support interpretation and impact assessment without breaking traceability or control. All analysis is performed strictly within validated sources and your defined regulatory scope.
Global coverage, with transparency
From the EU and the US to regional harmonisation initiatives such as GCC, ASEAN, and MERCOSUR. We are explicit about where coverage is fully curated and where professional judgement is still required. Transparency is part of regulatory control.
What this actually changes
The shift is not automation of judgement, but protection of it. Regulatory decisions remain contextual, traceable, and defensible over time — turning regulatory control into a continuous, audit-robust practice rather than a document exercise.