Lexim helps Lifesciences companies track and manage regulatory information, speed decision-making, accelerate time-to-market, and reduce regulatory risk. Lexim's solution, RegIntel, gives Regulatory, Quality, Safety, Manufacturing, Product, and all other stakeholders a comprehensive view of the global regulatory landscape with clear analyses of impact and actions to take. With RegIntel, you may:
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Track regulations and updates daily from around the world (20+ major markets)
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Receive detailed analysis and insights into regulations including recommended actions to take and impact on your business
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Find answers to regulatory questions in seconds from millions of documents and datasets, including rules, guidances, and acts, using plain English queries
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Discover data trends from sources such as MDR/Maude, Warnings, Recalls, and more
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Share insights and collaborate with stakeholder teams such as Quality, Safety, Manufacturing, Partners, or others
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Add your documents, datasets, or spreadsheets for instant analysis and insights
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Translate regulatory and related documents to and from 50+ languages instantaneously
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Automate regulatory tasks using a library of workflows, as well as create your own
Lexim RegIntel was designed for Regulatory Professionals by Regulatory Professionals. It is an Agentic AI application that uses an ensemble of Generative AI models tuned for life-sciences regulatory affairs. It delivers deep value to its customers. The solution pays for itself in a few short days.
Our Clients and Partners
Save Time.
Lexim aggregates regulatory documents from 20+ countries into a single repository and keeps you abreast of updates. Easily find information in guidelines, warnings Maude datasets, rules, acts, and more using plain English questions. Save time otherwise spent tracking websites and emails.
all regulatory information in one place
focus on what's relevant
Make Faster Decisions.
You may subscribe to documents and data records, such as Maude, that match your business interests. Receive notifications of any change. Reduce noise. Make faster decisions.
increase understanding of regulatory texts
Accelerate Time to Market. Reduce Risk.
Leverage AI-powered applications tailored for the life science industry to analyze and interrogate complex regulatory documents to receive recommendations for impact and actions. Bring your own documents for analysis. Accelerate time to market and reduce risk with a better understanding of regulations among stakeholders.
automate rote tasks
Automate. Become More Effective.
Perform rote tasks using highly effective automation tools. Write briefs, fill out forms, and extract information with just a button click. Define your automation tasks and share them with your team to save enormous amounts of time for the enterprise.
For Pharma and MedTech
Understand Rules and Guidances
RegIntel™ provides Access to high-quality AI-generated summaries, impact analyses, action item lists, and FAQs of regulatory documents relevant to your medical device. These insights help you quickly understand how the stated regulations or guidance affect the development of your device.
Use Powerful Document Search
Use the built-in powerful search function with multi-faceted filters to quickly find the records or documents you need. Search options are tailored to the type of record or document, making it easy to specify precise search criteria.
Build a Collection of your own Regulatory Documents
With RegIntel™, you can mass upload your own regulatory documents and generate the same AI-driven high-value summaries, impact analyses, action item lists, and FAQs as those created for documents already uploaded by Lexim. Additionally, if you upload non-English documents from foreign agencies, you can translate the generated AI outputs into English.
Awareness of Important Dates and Potential Issues
View and track documents relevant to your business such as calendar items that track dates for final comment submissions, program-specific notices issued by agencies, or warning letters all easily accessible in RegIntel™
Additionally for Med Device
Connect the Dots
Device Intelligence offers you a unified environment allowing you to conduct efficient research into MedTech company registrations and MedDevice classifications, while also cross-referencing them with 510(k) certifications and Premarket Approvals for efficient predicate search.
Research Incidents and Device Recalls
Search a comprehensive dataset of Adverse Event reports (MAUDE/MDRs) and Device Recalls to identify issues reported by healthcare providers and patients concerning medical devices similar to yours.
Business Impact
250+
global agencies
10M+
documents and datasets
1000
average hours saved by RegIntel™ per user per year
3
patents pending