19 May

[Blog] Starting Strong as a CMO: Your Serialization & Compliance Strategy for Europe and Beyond

Table of Contents

Why Serialization Compliance Is Critical for New CMOs

Starting your journey as a Contract Manufacturing Organization (CMO) in the pharmaceutical industry requires more than production capabilities. Whether you’re operating in the European Union only or expanding into international markets like the United Arab Emirates, your ability to provide compliant serialization, aggregation, and data exchange services is critical to your long-term success.

Your Marketing Authorization Holder (MAH) clients rely on you to deliver traceability solutions that meet diverse regulatory requirements—without delay or risk.

Here’s how you can build a serialization and compliance strategy that’s audit-ready, scalable, and future-proof—powered by the SATT PLATFORM.

Regulatory Compliance Setup: Getting It Right from the Start

Primary Objective: Ensure serialization and packaging compliance aligned with target market regulations.

For CMOs operating in Europe:

Comply with EU Falsified Medicines Directive (FMD): Every prescription pack must include a GS1-compliant 2D Data Matrix code and tamper-evident closure (e.g., seals, labels, or perforations).
Be technically ready to support EMVS connections: While MAHs connect directly to the European Medicines Verification System, CMOs must generate validated data to hand over to their clients.
Understand country-specific variations: For instance, Germany requires the PZN (national reimbursement number) to be encoded in the Data Matrix.
Maintain full traceability and documentation: Ensure robust audit trails for rework, returns, and decommissioning.
Apply a GxP-compliant Quality Management System: Align with Annex 11, GAMP5, and GMP to support system validation and data integrity.

For CMOs operating in Europe and the UAE:

Comply with the UAE’s Tatmeen traceability system.

Requirements include:

GS1-standard 2D Data Matrix serialization
Mandatory aggregation at secondary and tertiary packaging levels
Secure data exchange with the MAH for Tatmeen reporting

The SATT PLATFORM supports both EU and UAE serialization frameworks, allowing a single configuration logic across jurisdictions—simplifying global compliance.

Serialization, Aggregation & Tamper-Evident Capabilities

Primary Objective: Build infrastructure to support multi-market serialization operations.

Serialization setup:

High-resolution printers (thermal, inkjet, or laser)
Vision systems for print inspection and verification
Rejection units for non-compliant products

Tamper-evident labelling:

Security seal applicators for carton-level protection

Aggregation setup:

Manual or automated stations to capture parent-child hierarchies (e.g., pack-to-carton, carton-to-pallet)
High-speed vision systems to scan multiple codes at once

Note: Aggregation is not mandatory under EU FMD, but is increasingly required by MAHs—especially for export to countries like the UAE.

The SATT PLATFORM seamlessly captures data from your serialization and aggregation lines, enabling:

Per-customer configuration
Real-time visibility
Scalable Level 2–4 integration across clients and products

Digital Integration & Data Exchange

Primary Objective: Deliver secure, validated, and flexible data transfer to MAHs.

As a CMO, you don’t report to regulatory authorities directly (Level 5), but your systems must support MAHs by generating:

Batch-level serialization and aggregation data
Data files for real-time or batch transfer via SFTP, APIs, or custom exports
Clear product hierarchies for multi-tenant environments

Your system must also be ready to:

Feed data to the EMVS (via the MAH)
Provide compliant data structures for Tatmeen (via the MAH)

With SATT PLATFORM, you get:

Full control over serialization logic and batch traceability
A secure, multi-client setup to keep MAH data separate and compliant
Standardized processes that reduce onboarding time and operational risk

Differentiation & Market Readiness: Stand Out as a CMO

Primary Objective: Position your CMO as a ready, reliable, and future-focused partner.

Define your offering:

Serialization & Tamper-Evident Application
Serialization + Aggregation Services
Serialization + Digital Data Management (Level 3–4 scope)

Showcase your readiness:

Validation aligned with Annex 11, GAMP5, and ISO standards
Flexible templates for fast MAH onboarding
Transparent audit trails, batch reports, and rework management

With SATT PLATFORM, CMOs benefit from:

Enterprise-level scalability
Modular compliance management
Advanced reporting and traceability dashboards for MAH collaboration

Compliance Is Your Competitive Advantage

For pharmaceutical CMOs, serialization and compliance are not optional—they are business-critical. Whether launching in Europe or supporting dual-market operations in the UAE, your infrastructure must meet regulatory and client expectations.

The SATT PLATFORM provides the control, compliance, and configurability needed to succeed in regulated markets. It is backed by global experience and trusted by leading pharmaceutical companies.

Ready to streamline your serialization operations and scale with confidence? Talk to our experts today.