Lexim Sphere
The Command Center for
Global Regulatory Intelligence.
Purpose-Built Engines running continuously across your regulatory landscape monitoring, analyzing, gap-testing, translating, and alerting. Powered by Synthesis, the world's regulatory data library, and your own documents in Cabinet. One operating environment. Built for the world's most regulated industries.
Trusted by Regulatory Leaders in MedTech Pharma Medical Devices Life Sciences
The Platform
One ecosystem. Four forces.
Purpose-Built Engines. A global regulatory data library. An FDA device data universe. A secure document workspace. Four integrated components built to work together, or powerful individually.
SYNTHESIS
The End of the Raw PDF.
15 countries. Real-time regulatory feeds. Pre-analyzed with our proprietary Synthesis Six layers of intelligence, from Business Impact to Action Items delivered the moment a regulation changes.
Targeted Automation. High-Stakes Precision.
Purpose-built AI agents that monitor, map, analyze, compare, translate, and remediate running continuously across your regulatory landscape. From competitive radar to SOP gap analysis to ISO-standard translation. This is where intelligence becomes action. Running 24/7 so your team doesn't have to.
ENGINES
DEVICE LENS
Surveillance, Not Just Statistics.
The complete FDA medical device data universe, 510(k) clearances, PMAs, MAUDE adverse events, Recalls, and Classifications; aggregated, searchable, and activated by the Periscope Engine for competitive and safety intelligence.
CABINET
Where Your IP Meets Our Engines.
Your secure, siloed intelligence hub. Store your SOPs, ISO standards, ASTM specs, and internal materials, then activate them with our Engines to stress-test strategy against the global regulatory landscape.
The Engines
One regulatory AI
two distinct expressions
The Synthesis Six apply our AI automatically to every regulatory document released by global authorities, delivering structured intelligence the moment it publishes. The Engines deploy the same AI on demand, to solve your most specific and demanding compliance challenges. Synthesis, Device Lens, and Cabinet are the foundation. The Engines power your understanding and response. Here are just two examples:
Strategic Engine · Live Monitoring
Periscope
Your Competitive Radar. Always On.
Select the companies and FDA product codes you want to watch. Periscope monitors Device Lens data, Press Releases, Clinical Trials, and FDA Enforcements simultaneously and alerts you the moment anything happens via email, dashboard, and Sphere feed.
Execution Engine · Gap Analysis
Bridge
Find Every Gap. Plan Every Fix.
Select the companies and FDA product codes you want to watch. Periscope monitors Device Lens data, Press Releases, Clinical Trials, and FDA Enforcements simultaneously and alerts you the moment anything happens via email, dashboard, and Sphere feed.
The Lexim Advantage
Stop the
'Search and Rescue' mission for regulatory data.
From Awareness to Action Plan in minutes, not days. Lexim Sphere is built for the speed and precision that Life Sciences professionals demand, and that legacy solutions have never delivered.
Six layers of intelligence.
Every regulation. Instantly.
Every regulatory update in Lexim Sphere is pre-analyzed through our proprietary Synthesis Six framework automatically so your team arrives at every document with intelligence already applied. The same six layers that power the Engines are at work the moment a regulation is published.
Summaries
Two levels of clarity in one. A concise executive summary for immediate situational awareness, plus a detailed structured summary for teams that need the full picture, without ever opening the source document.
Impact Analysis
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Cross-functional impact mapped by department — Regulatory, Quality, Clinical, Legal, Commercial. Know exactly which teams are affected, how, and how urgently, the moment a regulation is published.
Action Items
Prioritized tasks extracted directly from the regulatory text and organized by function. Not generic checklists specific, document-sourced action items assigned to the teams responsible for compliance.
FAQs
Anticipated stakeholder questions answered in plain language before they're even asked. Accelerate internal alignment and equip every function with the clarity they need to move from awareness to action.
Supporting Materials
Every related regulation, guidance document, and standard linked and pre-analyzed. Navigate the full regulatory ecosystem around any document without leaving Sphere, each connection carrying its own Synthesis Six intelligence
Discussion Tracking
Built-in organizational assessment and collaborationdirectly on the document. Capture internal debate, decisions, and ownership as your team evaluates impact, so institutional knowledge is never lost in an email thread.
Lexim Cabinet
Where Your IP
Meets Our Engines.
Your SOPs, standards, submissions, and policies stored securely and activated by every Engine in the suite. Don't just store your documents. Run them through Bridge. Translate them with Relay. Compare them with Clarity.
Zero-Training Guarantee.
YOUR DATA. ALWAYS YOUR.
Your documents are never used to train our models or anyone else's. Every Cabinet is completely siloed from every other customer on the platform.
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No cross-contamination between customers
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Documents never used for model training
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An architectural guarantee — not a setting