Service 01 of 06
Regulatory Compliance Advisory
We turn EU technical regulations — including the EU AI Act (Reg. (EU) 2024/1689) — into working compliance systems: obligation-mapping software, conformity-tracking tools, and documentation platforms your team actually uses.
What We Do
Concrete deliverables, not a slide deck.
We work across any regulated domain — product safety, digital services, environmental standards, financial compliance, and the EU AI Act (Reg. (EU) 2024/1689) — for manufacturers, importers, distributors, service providers, and public bodies.
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01
Obligation-mapping systems
A live system that identifies every applicable EU and national requirement for your product, service, or platform, cross-referenced to source legislation and kept current as regulations change.
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02
Conformity-pathway tooling
Dashboards that surface the conformity assessment pathway for your product category — including when a notified body is required — so your team tracks status without guesswork.
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03
Documentation management platform
A platform that manages technical files, declarations of conformity, and labelling against current regulatory requirements, flagging gaps before they become findings.
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04
Compliance automation tools
Digital tools we build that track ongoing obligations — including AI Act obligations — so compliance doesn't lapse between audits.
The EU AI Act (Reg. (EU) 2024/1689) applies to providers and deployers of AI systems. We map your obligations and build the compliance tooling to meet them. This is informational context, not legal advice.
Who It's For
Anyone with a regulatory obligation and no time to guess at it.
- Manufacturers and importers bringing a product to the EU market
- Distributors responsible for downstream compliance checks
- Service providers navigating digital or financial regulation
- Public authorities drafting, applying, or overseeing regulatory requirements — including the EU AI Act
How We Work
A scoped engagement, not an open retainer.
Scope
We define which regulations, products, or activities are in scope and agree the deliverable upfront.
Build
We build the mapping, tracking, or documentation system your regulatory position requires.
Deliver
We ship a working system your team can use immediately, with the underlying regulatory analysis built in.
Own
You own it going forward. We keep it current as regulations change, or hand it fully to your team.
Related Services
Often paired with this engagement.
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03
Regulatory Readiness & Impact Assessment
Know where you stand before a launch, market entry, or audit.
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02
Market Surveillance & Enforcement Support
Framework design and tooling for market surveillance and enforcement bodies.
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06
EN 18286 AI Quality Management Systems
Audit-ready AI quality management for the EU AI Act.
Your regulatory challenge has a specific answer. Let's find it.
Based in Malta, operating across the EU. First conversation is no charge.