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Quality Management System | Clarit

Agentic QMS that turns your documents, CAPAs, and audits into a living system — not a shelf of SOPs.
Regulatory Intelligence | Synthesis

Tracks global regulatory changes in real time and tells you exactly how they affect your products.
Competitive Intelligence | Periscope

Monitors competitor filings, approvals, and market moves so you won't be caught off guard.
Labeling & Compliance | Composit

Checks labeling and marketing claims against current regulations before products leave the door.
Global Submission Preparation | Folio

Assembles and formats regulatory submissions for every market you're filing in, from one workspace.
SOPs & Templates | Cabinet

A single source of truth for SOPs and templates, version-controlled and always audit-ready.
Market Pathway | Strategizer

Maps the fastest compliant path to market across jurisdictions, tailored to your product profile.
Solutions
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MedTech

Stay ahead of QMSR, 510(k), and post-market surveillance requirements without adding headcount.
Pharma

Navigate FDA/EU MDR pathways, labeling, and post-approval compliance as regulations shift.
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VP Regulatory

See regulatory risk across your whole portfolio before it becomes a filing delay.
C-Suite/Executive

Board-ready visibility into compliance posture, audit readiness, and regulatory exposure — no translation needed.
QA Managers

Keep CAPAs, audits, and Form 483 responses on track without chasing documents across systems.
RA Specialist

Cut submission prep time with a system that already knows each market's requirements.
RI Analyst

Track regulatory changes as they happen instead of discovering them in a competitor's filing.
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COMPANY
About Us

Why we built an operating system for regulatory and quality and what we believe it should do differently.
Security & Trust

How we protect your data — encryption, access controls, and compliance standards, in plain terms.
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Resources > Articles

Regulatory Intelligence,
In Depth.

Articles, whitepapers, guides, and case studies for Life Sciences regulatory professionals navigating a faster, more complex regulatory world.

Lexim AI cover: UK international recognition and reliance pathways for medical devices

International Recognition and Reliance Pathways: The UK’s New Model for Device Access

The UK's draft International Reliance pathway would let device manufacturers build on approvals from trusted regulators such as FDA, TGA, and Health Canada to reach the Great Britain market faster. What's proposed, what's confirmed, and how to plan multi-market strategy.

Regulatory

Sep 224 min read

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Resources > Articles

Regulatory Intelligence, In Depth.

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International Recognition and Reliance Pathways: The UK’s New Model for Device Access

Regulatory Intelligence,
In Depth.