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.
500+
REGULATORY SKILLS
& AGENTS
100,000+
DOCUMENTS & STANDARDS
100+
JURISDICTIONS
100M+
LIFE SCIENCE DATAPOINTS
MEDICAL DEVICES PHARMA & BIOLOGICS SAMD LIFE SCIENCE ISO 13485 ISO 14971 IEC 63204 IEC 62366 IEC 60601
Regulatory demands are relentless, consequential, and growing.
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Fast-changing technologies create competition requiring greater speed to market
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New technologies mean new regulation — eliminate blind spots before they become gaps
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Regulatory bodies are using AI for significantly increased scrutiny — your team needs the same advantage
Lexim Sphere puts control in the hands of quality and regulatory professionals.
Find what you need
The right information, before you need to ask for it.
Every regulatory update analyzed. Every competitor filing monitored. Every predicate candidate surfaced. Lexim Sphere delivers the intelligence your team needs before the question lands on someone's desk — across 100+ jurisdictions, continuously.
Concept to launch
Quality Management — fully agentic, from first requirement to submission.
AI-driven design controls, risk analysis, and V&V — compliant to ISO 13485 and ISO 14971, with SaMD modules compliant to IEC 62304. Increases speed to market, identifies and helps mitigate regulatory risks, generates test cases, and more.
Get to market and stay there
Submissions that clear. Labels that travel. Markets that stay open.
Folio structures submissions from day one and checks completeness continuously. Composit keeps labels current in every market. Vigil and Periscope ensure nothing in the regulatory environment changes without your team knowing. Getting to market is one milestone — staying there requires every domain, running continuously.