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Pharma Serialization and Regulatory Compliance Software

Global Pharma Compliance,Simplified. Intelligent. Assured

One platform for multi-market compliance, serialized reporting, and audit-ready operations

GlobalFootprints
SeamlessIntegration
RegulatoryAudit Ready

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 logo

GS1 Standards

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

EPCISCBVGTIN / SSCC
ISO/IEC 27001:2022 logo

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 logo

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 logo

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

Trusted Solutions. Smarter Operations.

Primary Strip Machine for pharmaceutical packaging lines

Primary Strip Machine

Delivers high-speed code printing and verification for tablets packed on primary strip lines.

Primary Blister Intermediate for pharmaceutical packaging lines

Primary Blister Intermediate

Prints, serializes, and verifies codes on blister packs while integrating smoothly with the primary line.

Secondary PVR Inline System for pharmaceutical packaging lines

Secondary PVR Inline System

Inline carton serialization, 20MP vision inspection, checkweigher interlock, and automated rejection.

Vision Inspection Solution for pharmaceutical packaging lines

Vision Inspection Solution

360° multi-point high-speed vision inspection, OCR/OCV verification, label integrity, and defect detection at 900 PPM.

Primary Tube for pharmaceutical packaging lines

Primary Tube

Applies and verifies traceability codes on pharmaceutical tubes without interrupting production flow.

Bundler Machine for pharmaceutical packaging lines

Bundler Machine

Groups finished cartons into secure, consistent bundles for efficient end-of-line handling and dispatch.

Tamper-Evident Machine for pharmaceutical packaging lines

Tamper-Evident Machine

Applies tamper-evident seals accurately to protect pack integrity and reveal unauthorized opening.

Bulk 2D Aggregation for pharmaceutical packaging lines

Bulk 2D Aggregation

Captures and links multiple 2D codes in bulk to build accurate carton-level aggregation and traceability records.