The Challenge
Why Healthcare makes Multi-Jurisdiction Expansion harder than it looks.
A pharmaceutical company running clinical trials across US, EU, and UK faces FDA, EMA, and MHRA regulatory requirements simultaneously — each with distinct data integrity, audit trail, and submission format requirements. A system that satisfies FDA 21 CFR Part 11 does not automatically satisfy EU Annex 11. We architect the validated infrastructure that satisfies all three.
Compliance Frameworks
fda 21 cfr part 11
hipaa
soc 2
Methodology
How We Deliver in Healthcare
FDA-grade engineering for clinical and commercial systems. Every engineer assigned to this engagement understands healthcare before they write their first line of code. Compliance frameworks — FDA 21 CFR PART 11 and HIPAA — are enforced at every commit, not assessed at the end.
✓Healthcare-qualified engineers assigned before kickoff
✓FDA 21 CFR PART 11 compliance mapped to architecture on day one
✓Production-ready output — not prototypes or proof-of-concept
✓Automated compliance monitoring through ALICE at every commit
✓Full IP ownership transferred at engagement close
Engagement Model
How We Engage
Tier II
Enterprise Program
Parallel engineering tracks with integrated compliance governance and dedicated program management.
Tier III
Total Infrastructure
Full-scale infrastructure programs spanning multiple jurisdictions, regulatory frameworks, and technology stacks. Our complete engineering force at enterprise scale.
Embedded Capabilities
Platforms Deployed
These aren't products we sell. They're capabilities embedded in every engagement of this type.
ProofGrid
API Compliance Verification
Every integration our engineers build gets ProofGrid compliance monitoring as standard. It's why our API architectures don't create compliance gaps that surface during audits.
Regure
Regulatory Intelligence
Our teams deploy with live regulatory monitoring. When HIPAA, GDPR, UAE PDPL, or FCA frameworks change, Regure flags it and queues the engineering response before the client's legal team finishes reading the announcement.
ALICE
QA & Compliance Engine
This is the single most important reason our teams deliver compliance-native systems. ALICE makes it mechanically impossible to ship non-compliant code. It's not a QA phase — it's infrastructure-level enforcement at every commit.
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