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Products
CORE PLATFORM
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
BY INDUSTRY
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.
BY ROLE
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.
Resources
Company
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.
Contact Us

Talk to the team about a demo, a partnership, or more.
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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: EU MDR Transition Deadlines under Regulation 2023/607

EU MDR Transition Deadlines: What Regulation 2023/607 Really Requires Before 2027

What Regulation (EU) 2023/607 requires before the 2027 and 2028 MDR deadlines: legacy device conditions, EUDAMED, the 2025 simplification proposal and a close-out plan.

Regulatory

Sep 2210 min read

Lexim AI cover: The EU AI Act and AI medical devices before August 2028

The EU AI Act and AI Medical Devices: What Changes Before August 2028

How the EU AI Act applies to AI-enabled medical devices after the 2026 Digital Omnibus: high-risk classification, Articles 9–17, MDCG 2025-6 and an integration plan.

Regulatory

Sep 220 min read

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Resources > Articles

Regulatory Intelligence, In Depth.

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EU MDR Transition Deadlines: What Regulation 2023/607 Really Requires Before 2027

The EU AI Act and AI Medical Devices: What Changes Before August 2028

Regulatory Intelligence,
In Depth.