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
MES
“We replaced paper batch records across 12 production lines in under 4 months. Exception handling that used to take hours is now flagged and resolved in real time on the shop floor.”
Head of ManufacturingTop 10 Global PharmaLogbooks
“Our equipment and area logbooks were the last paper holdout. Digitising them eliminated transcription errors and gave us instant traceability during audits. Inspectors can now pull any logbook entry in seconds.”
QA DirectorMulti-site API ManufacturerDocument Management
“SOP version control was a constant audit finding for us. The document app gave us automated change control, e-signatures, and a single source of truth across all our facilities.”
Head of Quality SystemsSpecialty PharmaAI
“The AI handles deviation investigations that used to take our team days, reviews batch records against specifications automatically, and flags SOP non-compliance before it becomes a finding. It is not a chatbot — it actually acts on our data.”
VP QualityGlobal CDMOCLEEN
“HBEL calculations that took our validation team weeks are now generated in minutes with full traceability. We cut our cleaning validation cycle time by 80% and eliminated manual calculation errors entirely.”
Head of ValidationMulti-site Generics ManufacturerLeucineOS
“Having MES, quality, and compliance on a single platform changed how we operate. Our teams across 30 facilities finally work from the same data instead of reconciling spreadsheets.”
Chief Operating OfficerTop 20 PharmaCustomer Support
“The support team understands pharma manufacturing — they do not just close tickets. During our FDA inspection, they were on call with us and helped us pull audit trail reports in real time.”
IT DirectorBiotech ManufacturerImplementation
“We went live across 7 facilities in 5 months, including validation and training. The implementation team had done this enough times that they anticipated our challenges before we hit them.”
Digital Transformation LeadGlobal Pharma Manufacturer
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.
