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AI Regulatory Intelligence Software for MedTech & Pharma
Faster to market, lower regulatory risk, complete global coverage.
Lexim Sphere.
The regulatory operating system for Life Sciences: fully automated with AI agents, from feasibility to quality to submissions to post-market surveillance in half the time.
Frequently Asked Questions
01
How does Lexim differ from a traditional RIM?
Traditional RIM systems are largely repositories — teams manually enter and track regulatory data. Lexim Sphere is an AI-driven regulatory operating system: AI agents actively monitor regulations, run gap analysis, and support submissions across the full product lifecycle, from feasibility through quality management to post-market surveillance — automating work a RIM only stores.
02
Is Lexim 21 CFR Part 11 compliant?
Lexim Sphere is built on single-tenant architectural isolation, full audit trails, and version-controlled documentation designed to support regulated workflows. Formal certifications are part of our ongoing roadmap — contact us for current compliance documentation and Part 11 specifics for your evaluation.
03
Does Lexim cover both MedTech and Pharma?
Yes. Lexim Sphere supports both industries natively — regulatory intelligence, design/risk/quality, labeling, and submission workflows for MedTech (ISO 13485, ISO 14971, 21 CFR 820, IEC 62304) and dedicated drug approval and lifecycle intelligence for Pharma.
04
What does implementation look like?
Implementation starts with a demo scoped to your regulatory context and product categories, followed by Cabinet setup, integration configuration, and team training.
05
How long does onboarding take?
Most teams are fully onboarded within 1–3 weeks, depending on integration scope and data migration needs.
06
Does Lexim integrate with existing QMS systems?
Yes. Lexim connects with the tools regulatory and quality teams already use, including eQMS platforms, Jira, GitHub, and Solid Edge, so design, risk, and quality data flow into Lexim without duplicate entry.
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