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RegIntel™

Regulatory Clarity in Minutes—Not Months

Global Regulatory Intelligence for Life Sciences

Navigate global regulations with

unprecedented speed, clarity, and accuracy

​

RegIntel™ unifies regulatory research, AI-driven analysis, and automated workflows, empowering medical device, pharmaceutical, and consulting teams to stay compliant, reduce risk, and accelerate market access.

Immediate, Measurable Impact

Across Your Regulatory Function

Save hundreds of hours per year by eliminating manual document searching and interpretation.

Improve team alignment with a centralized, shared regulatory source of truth.

Standardize requirement interpretation and application to enhance consistency and quality across teams.

Reduce compliance risk with always-updated regulatory intelligence.

Shorten global market entry timelines through faster requirement analysis and submissions preparation.

Boost decision-making confidence with data-backed insights, not assumptions.

Key Capabilities

Comprehensive, AI-Driven Regulatory Intelligence

Global Regulatory Coverage

One Source of

Regulatory Truth

Eliminate fragmented tools and align teams around a single, centralized regulatory intelligence hub.

Authoritative Sources

You can Trust

Access content directly from leading regulatory bodies, decreasing manual searches.

80+ Countries,

Instantly Accessible

Navigate global regulations, standards, and guidance from one unified, always-up-to-date platform.

AI Agents & Workflow Automation

Automate Repetitive Regulatory Work

Offload document reviews, comparisons, and summaries to AI agents.

Accelerate

Submissions Preparation

Generate structured outputs that reduce manual effort and review cycles.

Scale Regulatory

Capacity Instantly

Increase throughput without adding headcount.

Smart Document Interaction

Communicate within

Regulatory Documents

Instantly surface relevant sections without scrolling through hundreds of pages.

Side-by-Side

Market Comparisons

Compare requirements across regions to align global strategies faster.

Visualize

Regulatory Differences

Quickly identify overlaps, gaps, and divergences that impact compliance.

Real-Time Data Insights

Millions of Data Points

at your Fingertips

Leverage global regulatory intelligence to inform strategic decisions.

Stay Current with

Live Updates

Track regulatory changes, approvals, and trends as they happen.

Data-Driven

Regulatory Strategy

Replace assumptions with insight-backed planning and execution.

Tailored for Every Segment

of
Life Sciences.

Medical Device Manufacturers

RegIntel™ provides an AI-driven overview of global device regulations and market-entry requirements to streamline design control and expedite submissions.

 

Key Features include:

  • Access to MDR, IVDR, FDA guidance, and global standards

  • AI-supported reviews of safety/performance requirements  

  • Faster preparation for audits and documentation, reducing complexity across markets and product families.

Pharmaceutical Teams

RegIntel™ centralizes global pharmaceutical regulations, using AI to clarify key requirements and streamline research across GxP, clinical, and labeling.

 

Key Features include:

  • Centralized access to drug regulations  

  • Faster interpretation of GCP, GMP, GLP, and submission guidelines  

  • Predictive insights for global filings  

  • Accelerated launch preparation

Regulatory Consultants

RegIntel™ helps consultants and advisory firms efficiently scale regulatory services. AI-driven research speeds up project kickoffs, compliance assessments, gap analyses, and multi-market strategy development.

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Key Features include:

  • AI-assisted research for quick client delivery  

  • Custom outputs for market assessments + regulatory plans  

  • Enhanced accuracy and consistency  

  • Higher-value, insight-driven regulatory services  

See Lexim RegIntel™ in Action

Thank you. We will be in contact.

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