NewBuilt for USA Pharma · India-ready

Track every unit. Own every market.

Purpose-built for US drug manufacturers — native DSCSA compliance, FDA ESG submissions, VRS verification. With full CDSCO & India T&T support for global rollouts. AI anti-counterfeit and built-in WMS — live in days, not months.

See all features
4
markets supported
5 days
to go-live
99.99%
platform uptime
Serialization platformLIVE
2.4M+
serials per platform tenant
EPCIS evt/sec
5,000+
Markets
4
Scan accuracy
99.4%
Key markets
US
USAPrimary
DSCSA · FDA ESG · VRS
IN
IndiaSecondary
CDSCO · iVEDA · NHRN
Compliance score+2.4% MoM
Compliance certified
21 CFR Part 11
SOC 2 Type II
ISO 27001
GxP Validated
GS1 EPCIS 2.0
USA-first · India-ready

Built for US pharma. Ready for India.

Our primary focus is the US pharmaceutical market — DSCSA, FDA ESG, VRS. India is a fully-supported secondary market, configured at onboarding for global manufacturers.

Primary market
US
United States
DSCSA-ready before November

Our core focus. End-to-end Drug Supply Chain Security Act compliance — from EPCIS interoperability through saleable-return VRS verification.

120+
ANDA filers served
Native
FDA ESG submissions
All major
VRS partners
EPCIS 1.2 + 2.0 interoperability
FDA ESG direct submission
GS1 US healthcare standards
Saleable return VRS network
21 CFR Part 11 audit trail
Secondary market
IN
India
CDSCO & iVEDA support

Full alignment with India's Track & Trace mandate — CDSCO portal, NHRN dual barcoding, and iVEDA exports for global manufacturers.

80+
WHO-GMP exporters
Live
DGFT integrations
8 months
Avg ROI
CDSCO portal direct upload
NHRN-compliant dual barcode
iVEDA / DAVA export flows
State-level GST + GSTIN aware
Multi-language UI options
Also servingEUEU FMD / NMVSSASaudi SFDA
Platform

Beyond compliance. Built for intelligence.

Purpose-built modules that go further than any SAP or legacy platform. No middleware. No integration debt.

GS1 Serialization Engine
Generate millions of SGTIN-96 serials with GS1-compliant barcodes (DataMatrix, GS1-128, QR). Batch up to 2M serials, FEFO lifecycle, and 90-day reservation pools.
SGTIN-96SSCCDataMatrix
EPCIS 2.0 Event Repository
Capture and broadcast supply chain events at 5,000+ events/sec. Full GS1 CBV vocabulary, real-time lineage viewer, gap detection, and immutable audit trail under 21 CFR Part 11.
EPCIS 2.0TimescaleDB21 CFR Part 11
AI Anti-Counterfeiting
ML anomaly detection for clone attacks, velocity abuse, geographic clustering, and reuse patterns. ECDSA cryptographic signing per unit with automated quarantine workflows.
Clone detectionECDSAHSM
Native WMS Module
The only T&T platform with a built-in warehouse management system. Pack station, GR dock, FEFO inventory — all auto-generating compliant EPCIS events. Zero middleware required.
Pack stationFEFOZero middleware
Real-time Verification
Sub-500ms verification at point of dispense. Native VRS routing for DSCSA. EU NMVS real-time integration. Offline mode with signed manifests.
VRSNMVS<500ms p99
4-Market Compliance Out of Box
USA DSCSA, EU FMD/NMVS, India T&T, and Saudi SFDA — all configured at onboarding. Auto-routing to FDA ESG, EMVO, CDSCO, and SFDA portals.
DSCSAFMDIndia T&TSFDA
Industries

Built for your supply chain reality.

Deep domain profiles mean the platform ships pre-configured for your regulatory environment — not a generic toolkit.

Pharmaceutical
Complete serialization compliance across all four major regulatory mandates. From line-side commissioning to pharmacy dispense verification.
Pre-configured for
DSCSA saleable return VRS verification
EU FMD / 25-country NMVS integration
India T&T with NHRN + dual barcode
Saudi SFDA compliance
21 CFR Part 11 · GxP · 15yr retention
FMCG
End-to-end supply chain visibility for fast-moving consumer goods. Protect your brand from grey market diversion and counterfeit.
Pre-configured for
GS1 serialization at item & case level
Retail verification via QR + consumer app
Grey market diversion detection
3PL and CMO partner network
High-volume: 500M+ serials/year
Nutraceuticals
Navigate complex regulatory requirements across health supplement markets while protecting product integrity and consumer trust.
Pre-configured for
FDA dietary supplement labelling rules
Lot traceability for recall management
Expiry and FEFO management
Consumer authenticity QR scanning
Multi-market: US, EU, India, GCC
Why TraceXL

Enterprise-grade. Without enterprise overhead.

SAP Advanced T&T requires SAP S/4HANA, 18 months to implement, and per-object licensing that scales against you. We go live in days, on a flat subscription.

Live in 5 days
Full regulatory configuration in days, not months. Our team handles GS1 setup, regulatory portal connections, and staff training — start serializing this week.
Predictable flat pricing
No per-object serial fees. No surprise module add-ons. One subscription covering all markets, all users, and all transaction volumes.
Zero integration debt
Native WMS, EPCIS, VRS, and NMVS — all in one platform. No middleware, no enterprise bus, no bespoke connectors to maintain.
Compliance-first architecture
Built for 21 CFR Part 11, GxP, and GDPR from day one. Every action is audit-logged. Every serial is immutably tracked.
Head-to-head vs SAP ATT
SAP ATT
TraceXL
DSCSA compliance
✓
✓
EU FMD / NMVS
✓
✓
India T&T
Partial
✓
Saudi SFDA
Partial
✓
Native WMS
✗
✓
AI anti-counterfeit
✗
✓
Onboarding time
18 months
5 days
Per-serial fee
Yes
None
Pricing

Transparent pricing. No surprises.

Flat monthly subscription. All markets. All users. No per-serial fees.

Starter
$1,399/mo
For emerging manufacturers entering their first regulatory market.
Up to 500K serials/month
1 regulatory market
5 users
GS1 serialization engine
EPCIS 2.0 repository
Email support
Most popular
Enterprise
Custom
For global manufacturers with custom integration and compliance needs.
Unlimited serials & users
All 4+ regulatory markets
AI anti-counterfeiting
Native WMS module
VRS / NMVS integration
Dedicated CSM + onboarding
On-premise deployment
White-label option
24/7 enterprise support
TraceXL
Free personalised demo

See TraceXL in action.
Your data, your markets.

Book a 30-minute walkthrough with a compliance specialist configured around your products, markets, and regulatory requirements.

Live EPCIS event dashboard with your product catalogue
End-to-end serial lifecycle — commissioning to dispense
Regulatory portal simulations for your specific markets
ROI comparison vs your current T&T setup

Request your demo

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