Pharma Serialization and Regulatory Compliance Software

Integrated L5-L1 Serialization and Compliance Ecosystem

Authorities and Network

Report

Country-specific code exchange, including crypto codes where required
Regulatory, batch serialization and aggregation reporting
External supply-chain visibility and analytics

Enterprise Web Application

Control

Master data, serial-number and SSCC management
Centralized reporting, audit trails and regulatory submissions
Integration with MAH/CMO, ERP, WMS, plant and warehouse systems

Local Server Site Controller

Validate

Site-, batch- and location-level data control
Master-data synchronization with L4 and local batch execution
Code reconciliation, audit trails and secure ERP/line integration

Serialization Aggregation

Production Lines

Print and validate GS1 DataMatrix /QR Codes and batch details
Unit-to-shipper traceability with up to five-level aggregation
Event logging and optional biometric access control

Hardware

Devices

Industrial hardware for inspection, serialization and aggregation
Integration with packaging lines, PLCs, printers, cameras and vision systems

Vision Inspection

Blister inspection
Label inspection
Cap inspection
Weight checking
Cartoning (OCR, QR, 1D & 2D Codes)

Serialization / Aggregation

Labelling
Case packing
Palletising

Rework, Distribution & Recall

Rework
Warehouse operations
Pick and pack
Shipment
Recall

Built Around Global Compliance Standards

GS1 Standards

Supports global identification, traceability data exchange, and supply-chain interoperability through GS1 standards.

EPCISCBVGTIN / SSCC

ISO/IEC 27001:2022

Supports secure information management through ISMS, access control, risk governance, and data protection practices.

ISMSAccess ControlData Security

FDA 21 CFR Part 11

Supports electronic records, e-signatures, audit trails, and data integrity controls for regulated life sciences operations.

E-SignatureAudit TrailsData Integrity

GMP Quality

Supports GMP-aligned quality workflows with batch integrity, traceability, QA/QC controls, and document control.

Batch ControlQA / QCTraceability

Brands That Trusts Us

Compliance-Ready Pharmaceuticals

Traceable Agrochemicals

Engaging FMCG & Lifestyle

Country-specific Serialization and Reporting Rules

Uganda (NDA / NHPTS)

Framework: National Health Products Traceability Strategy
Status: Phased roadmap / implementation readiness
Code Format: GS1 DataMatrix readiness
Core Data: GTIN/Product ID, Batch, Expiry, Serialization where available/applicable

Azerbaijan (DVTİS / Dərman Vasitələrinin Təqib və İzləmə Sistemi)

Framework: Drug tracking & tracing system
Status: Mandatory; phased from 2024
Code Format: GS1 2D DataMatrix
Core Data: GTIN/Product Code, Serial, Batch/Lot, Expiry

Kenya (PPB)

Framework: Authentication & traceability standards for HPTs
Status: Standards issued; phased readiness
Code Format: GS1 DataMatrix readiness
Core Data: GTIN/Product ID, Serial where applicable, Batch/Lot, Expiry

UAE (Tatmeen)

Framework: National pharma track & trace
Status: Mandatory serialization & Tatmeen traceability
Code Format: GS1 DataMatrix
Core Data: GTIN, Serial, Batch, Expiry

Saudi Arabia (SFDA RSD / DTTS)

Framework: SFDA Drug Track & Trace
Status: Mandatory serialization, aggregation & reporting
Code Format: GS1 DataMatrix; SSCC for aggregation
Core Data: GTIN, Serial, Batch, Expiry, GLN/SSCC

Bahrain (NHRA-MVC / Bahrain T&T)

Framework: NHRA pharma traceability
Status: Mandatory; MVC provider transition notified
Code Format: GS1 DataMatrix
Core Data: GTIN, Serial, Batch/Lot, Expiry

Australia (TGA / TGO 106)

Framework: Serialization & DataMatrix standard for medicines
Status: Optional adoption; TGO 106 applies when serialization or GTIN DataMatrix is used
Code Format: GS1 DataMatrix
Core Data: GTIN, Batch/Lot, Expiry; Serial if used

Canada (GS1 Canada / Pharmacy Roadmap)

Framework: Community-led GS1 DataMatrix pharmacy roadmap
Status: 2025 scanning/readiness roadmap; no federal unit-serialization mandate
Code Format: GS1 DataMatrix / GS1-128
Core Data: GTIN, Batch/Lot, Expiry; Serial optional

Jordan (JFDA / GS1 DataMatrix)

Framework: Medicine identification & serialization
Status: Mandatory active from 1 Jan 2026
Code Format: GS1 DataMatrix
Core Data: GTIN, Serial, Batch/Lot, Expiry

South Africa (SAHPRA Traceability)

Framework: Health-products traceability roadmap
Status: Phased batch-to-unit serialization
Code Format: GS1 DataMatrix / GS1-128
Core Data: GTIN, Batch/Lot, Expiry, Serial; SSCC where applicable

Argentina (ANMAT / SNT)

Framework: National Medicine Traceability System
Status: Mandatory for listed/regulated medicines
Code Format: GS1 DataMatrix / GS1-128 / RFID
Core Data: GTIN, Serial, Batch/Lot, Expiry

Turkey (TİTCK / İTS)

Framework: National Pharmaceutical Track & Trace
Status: Mandatory
Code Format: GS1 DataMatrix / Karekod
Core Data: GTIN, Serial, Batch/Lot, Expiry

Kuwait (Kuwait MoH / GS1 Kuwait)

Framework: Pharmaceutical GS1 DataMatrix marking
Status: Mandatory GS1 DataMatrix marking
Code Format: GS1 DataMatrix
Core Data: GTIN, Serial, Batch/Lot, Expiry

Oman (MoH / DGMS GS1 Barcode)

Framework: Medicine GS1 identification & traceability readiness
Status: Mandatory GS1 barcode/serialization; no central platform confirmed
Code Format: GS1 DataMatrix / GS1-128 by pack level
Core Data: GTIN, Serial, Batch/Lot, Expiry; SSCC where applied

Egypt (EDA / EPTTS)

Framework: National pharma serialization, aggregation & track-and-trace reporting
Status: Mandatory: imports from 1 Feb 2026; local/bulk/packed products from 1 Aug 2026
Code Format: GS1 DataMatrix ECC 200
Core Data: GTIN, Serial, Batch/Lot, Expiry; SSCC/aggregation where applicable

Pakistan (DRAP T&T / GS1)

Framework: GS1 DataMatrix pharma track-and-trace
Status: Announced mandatory phased rollout from 9 Oct 2026
Code Format: GS1 DataMatrix; GS1-128/SSCC for tertiary where applied
Core Data: GTIN, Serial, Batch/Lot, Expiry; SSCC where applicable

Ethiopia (EFDA-MVC)

Framework: National pharma traceability hub & EPCIS event reporting
Status: EFDA-MVC active; EPCIS events from 3 Jun 2026; aggregation reporting from 1 Dec 2026
Code Format: GS1 DataMatrix; EPCIS/GS1 reporting
Core Data: GTIN, Serial, Batch/Lot, Expiry, GLN; SSCC/aggregation where applicable

Algeria (ANPP)

Framework: Pharma serialization & aggregation readiness
Status: Expected from 1 Jan 2027; final rules to monitor
Code Format: GS1 DataMatrix
Core Data: GTIN, Serial, Batch/Lot, Expiry; SSCC/aggregation where applicable

Rwanda (Rwanda FDA)

Framework: Pharma identification, data capture & sharing
Status: Mandatory phased traceability rollout
Code Format: GS1 DataMatrix / GS1-128 by pack level
Core Data: GTIN, Serial, Batch/Lot, Expiry, GLN; SSCC where applicable

Moldova (AMDM)

Framework: Medicine registration & EU-aligned labelling control
Status: EU-aligned readiness; no serialization mandate
Code Format: Barcode / GS1 DataMatrix where used
Core Data: Product ID/Reg. No., Batch/Lot, Mfg, Expiry, MAH/Manufacturer

Nepal (DDA / GS1 readiness)

Framework: Medicine registration & GS1 traceability readiness
Status: Awareness/readiness stage; no mandate confirmed
Code Format: Barcode / GS1 DataMatrix where used
Core Data: Product ID/Reg. No., Batch/Lot, Mfg, Expiry, Manufacturer

Tunisia (DPM)

Framework: Medicine registration & serialization readiness
Status: Draft/readiness stage; no binding mandate yet
Code Format: EAN-13 / GS1 DataMatrix readiness
Core Data: Product ID/Reg. No., Batch/Lot, Mfg, Expiry, MAH/Manufacturer

Ghana (FDA Ghana / PTS)

Framework: National pharmaceutical traceability strategy
Status: Phased implementation; unit serialization not fully mandatory
Code Format: GS1 DataMatrix; GS1-128/SSCC where applicable
Core Data: GTIN/Product ID, Serial where applicable, Batch/Lot, Expiry; SSCC where applicable