AI-Powered Platform
for Life Sciences
AI-native platform unifying quality, compliance, and production into one intelligent system.
Trusted by pharma leaders
around the world
Our platform powers pharmaceutical manufacturing operations across the globe, ensuring compliance and quality at every facility.
Hyderabad, India
MESAPI Manufacturing — powering digital batch records and real-time production monitoring across active pharmaceutical ingredient facilities.
Our Platform Applications
Purpose-built applications that work together on a single platform.
The AI-native operating system that unifies your pharma manufacturing stack into one compliant, intelligent platform.
/01
LeucineOS
Manufacturing Execution System that digitizes shop-floor operations with real-time batch tracking and electronic records.
/02
MES
Automate cleaning verification workflows with risk-based protocols and continuous monitoring for regulatory readiness.
/03
CLEEN
Stay ahead of FDA inspections, warning letters, and regulatory actions with AI-powered intelligence and alerts.
/04
FDA Tracker
We don't just implement software. We architect outcomes.
300+
Manufacturing facilities
10+
Countries
450k+
Users
100%
Successful implementations
Leucine Solution Architecting
Leucinians deliver mission-critical outcomes for your most important implementations—combining deep pharma domain expertise with AI-native technology to architect solutions that transform your operations.
What Our Customers Say
Top 10 Pharma
“LeucineOS transformed our batch release process. What used to take weeks now takes days, with full compliance built in from the start.”
SCSarah ChenVP QualityGlobal CDMO
“The AI-powered deviation management alone saved us hundreds of hours in investigation time. The platform just understands pharma manufacturing.”
MTMichael TorresHead of ManufacturingBiotech Manufacturer
“We went from paper-based batch records to fully digital operations in under 3 months. The team adoption was remarkably smooth.”
PSPriya SharmaDirector of OperationsSpecialty Pharma
“Audit prep used to be a nightmare. With LeucineOS, we are always audit-ready. Our last FDA inspection was the smoothest we have ever had.”
JMJames MitchellQA ManagerMid-size Pharma
“The unified platform approach means our quality, manufacturing, and compliance teams finally speak the same language. It has changed how we operate.”
AWAnna WeberChief Operating Officer
Leucine is the first AI-native platform built for pharmaceutical manufacturing—unifying quality management, regulatory compliance, and production operations into one intelligent system that powers your entire drug manufacturing lifecycle from raw materials to patient delivery.
