Agentic AI for Pharma
Manufacturing.
One platform connecting every team across the pharma enterprise. 21 CFR Part 11 and FDA Inspection Readiness from day one.
AI for every function
FDA ETP participantDeviation detection, CAPA closure, and inspection readiness.
ExploreManufacturing AIReal-time yield, OEE, and process-drift detection.
ExploreRegulatory AISubmission readiness, registration tracking, and commitments.
ExploreSupply Chain AIDemand forecasting, supply-risk alerts, and capacity planning.
Foundation apps for compliant operations
Shared object model
MESManufacturing executionEBR, production logbooks, and real-time batch intelligence.
QMSQuality managementEvery QMS module on one shared Part 11 model and audit trail.
CLEENCleaning validationAutomated HBEL limits, worst-case matrix, and protocols.
One platform
One object modelOne audit trail · Part 11One identity & loginCross-app automationsLeucine runs alongside your existing stack. SAP, LIMS, and automation systems stay connected as live sources; what it replaces is paper and legacy point tools, one module at a time.
Now it does.
The problem
Your systems record.
They don't act.
Pharma has spent a decade digitising. The data exists. It just never acts on what matters.
Root cause
No one sees risk across the enterprise
Quality, manufacturing, and regulatory data sit in separate silos at every site: no leader sees where failure is building until an inspection finds it.
Root cause
The early signal never reaches a decision
The warning is already in your data, sitting in reports no one reads between reviews until it becomes a failure or a recall.
The cost
Root cause surfaces at audit, not before
Tracing across LIMS, SAP, MES, and supplier systems takes days by hand, so risk surfaces at inspection after the batch has shipped.
Meet the Platform
Every product 21 CFR Part 11 native. Every one running on the same ontology.
Intelligence
Celestara
A nerve center for every function: Quality, Manufacturing, Regulatory Affairs, and S&OP, each with specialised AI agents running on your data.
FDA ETP participant. Four function-specific AI nerve centers.
Explore Celestara0
Products
0
Alert
0
Watch
0
Stable
0
Active drifts
Pantoprazole
40 mg
Metformin
500 mg
Atorvastatin
10 mg
Amlodipine
5 mg
Levothyroxine
50 mcg
Losartan
50 mg
Read your whole portfolio in ten seconds.
Live nerve center
10 products · 111 CQAs
Manufacturing execution
MES
Electronic batch records, production logbooks, and real-time batch intelligence across every line and site, 21 CFR Part 11 from day one.
Cipla: 30 facilities, 8,000+ staff, 84M+ data entries.
Explore MESStep 14 · Compression
Press B · Rotary 35-station
Weight Variation trending upward — 8 consecutive readings above process mean. Pre-compression blend uniformity check recommended before next IPC.
Quality management
QMS
AI-native quality management system: every QMS module reimagined from the ground up with autonomous agents, shared data, and zero compliance gaps.
Every QMS module rebuilt on a shared Part 11 data model.
Explore QMSAPI dissolution failure — Pantoprazole batch series
Equipment cleaning residue above limit — Line 4
Raw material OOS — microcrystalline cellulose Lot 22A
Documentation error — batch record backdating
Environmental monitoring excursion — cleanroom B2
3 of 7 open deviations share a common root cause: Line 4 cleaning SOP gap. Linking all three to CAPA-0891 will close them faster.
Cleaning validation
CLEEN
Automated HBEL calculations, worst-case matrices, and protocol generation: the full cleaning validation lifecycle, without the manual work.
Zydus: 80% faster validation cycles. Zero manual calculation errors.
Explore CLEENEquipment
High-Shear Granulator
VALIDATED
V-Blender 300L
VALIDATED
Tablet Press A
VALIDATED
Tablet Press B
PENDING
Film Coater
OOS
Planetary Mixer 60L
VALIDATED
Worst-Case HBEL Matrix
Worst-case API automatically updated: Furosemide (0.40 mg/cm²) replaced Methotrexate after portfolio change. 4 protocols recalculated.
Proven at Scale
Running in production at 400+ GMP facilities
Some of the world's highest-volume, most heavily inspected pharmaceutical manufacturers run on Leucine, including Cipla's Indore Unit 1, a WEF Global Lighthouse site.
Long Island, USA
Integrated quality management across deviation handling, CAPA, and change control for US-based pharmaceutical operations.
AI Bootcamp
Bring your data.
Keep the results.
A half-day working session where we point AI agents at your real data and let them work. Not a sales pitch.
- Half a day
- Your real data
- Agents run live
- You keep the output
- 1
Ingest
Your data, connected
LIMS · SAP · MES · 2.4M records
- 2
Detect
Deviation found
Weight variation 3.21% RSD · Batch 24-INJ-0892
- 3
Root cause
Traced across three systems
Pre-compression blend uniformity drift · Press B
- 4
Act
CAPA drafted
Blend time +90s · re-qualify Press B
Impact studies
Top pharma manufacturers.
Large scale deployments.
data entries captured
30 sites. 8,000+ credentialed staff. The world's largest paperless manufacturing deployment.
Read the Cipla study
facilities harmonised
FDA, MHRA, and EMA on one standard. 100% 21 CFR Part 11 from day one.
Read the Piramal Pharma study
days to review a batch
2,700 hours saved annually. 60% fewer manual entries.
Read the Valent BioSciences study
faster cleaning validation
HBEL calculations and worst-case matrices automated across 7+ facilities.
Read the Zydus Lifesciences study
paperless from day one
200M units of new capacity. 3 blocks. Never touched paper.
Read the Instapill studyFDA Tracker Free
Not ready for a demo?
Start with the signal.
FDA Tracker turns every warning letter, 483, import alert, and recall into AI-summarised intelligence, scored to your products, suppliers, and competitors. 148,000+ records since 2012. No credit card, full access from the first login.
- Warning LetterData integrity · Sterile fill-finish · NJ
Audit-trail gaps not investigated
94relevance - Form 483Aseptic process · API supplier · Gujarat
Media-fill failures, no CAPA
88relevance - Import Alert66-40 · Oral solids · Hyderabad
Detention without physical exam
71relevance - RecallClass II · Packaging · PA
Label mix-up, single lot
63relevance
Solution architecting
We don't just implement software. We architect outcomes.
Leucine's solution architects partner on-ground for your most important rollouts, pairing deep pharma domain expertise with AI-native technology to transform how your sites run. That is why every go-live succeeds.
On-ground deployment
Solution architects map, standardise, and configure every workflow at your sites, not over email.
Deep pharma domain
Built by people who have lived GMP, 483s, and multi-site inspections, not generic enterprise software.
Phased rollouts
Start with one line or logbook, prove equivalence, then expand. Compliance value from week one.
No failed go-live, ever
Zero failed rollouts across every customer deployment to date, including networks of 30+ sites. Solution architecting is why.
See the platform on your data.
A focused walkthrough of Leucine against your real operation: your deviations, batch records, and quality data. Live, not a slide deck.