Lexim AI | Regulatory Information Management

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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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Accelerate Medical Device Launch with RegIntel

From strategy to submission—go from hours to minutes with AI-powered regulatory intelligence.

250+

global agencies

10M+

documents and datasets

1000

hours saved by RegIntel™ per users annually

35+

global markets

All regulatory information in one place

Save time and stay compliant with one platform for global regulatory updates. Instantly find answers in 20+ countries’ guidelines, warnings, and datasets—no manual tracking needed.

Increase understanding of regulatory texts

Analyze your own regulatory documents with AI to get actionable insights, align stakeholders, reduce risk, and accelerate time to market.

Automate rote tasks

Automate repetitive regulatory tasks—write briefs, fill forms, and extract data with one click. Customize workflows and share them to save time across your team.

AI Solutions for Regulated Life Sciences

Purpose-Built for Regulatory, Clinical, and Quality Teams

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CORE PLATFORM

BY INDUSTRY

BY ROLE

COMPANY

Accelerate Medical Device Launch with RegIntel

​

From strategy to submission—go from hours to minutes with AI-powered regulatory intelligence.

​

All regulatory information in one place

​

Save time and stay compliant with one platform for global regulatory updates. Instantly find answers in 20+ countries’ guidelines, warnings, and datasets—no manual tracking needed.

Increase understanding of regulatory texts

​

Analyze your own regulatory documents with AI to get actionable insights, align stakeholders, reduce risk, and accelerate time to market.

Automate rote tasks

​

Automate repetitive regulatory tasks—write briefs, fill forms, and extract data with one click. Customize workflows and share them to save time across your team.

AI Solutions for Regulated Life Sciences

​

Purpose-Built for Regulatory, Clinical, and Quality Teams