Pharmaceutical Aggregation Solutions for Global Compliance

The global pharmaceutical industry is an ever-evolving and fast-paced environment that must always adapt to the needs of the patients while following the requirements of various national health organizations and governments.

But the question is: Why does our industry need to regulate such a well-oiled machine? The answer is simple. Counterfeit and fraudulent products are a lucrative business that is consistently on the rise, especially in the case of medicines, powered by the booming economy of online shopping, the flattening of the world and the opening of international borders.

Pharmaceutical Aggregation

What Is Pharmaceutical Aggregation?

Pharmaceutical aggregation is the process of linking each serialized product to its packaging hierarchy, bottle to box, box to case, case to pallet, creating a digital parent-child relationship. This enables seamless tracking across the entire supply chain, from production to patient delivery.
By building on serialization, aggregation helps manufacturers ensure global compliance, streamline logistics, and enable precise, efficient recalls.

Why Pharmaceutical Aggregation Matters for Compliance

The pharmaceutical industry operates under increasing scrutiny from global regulatory bodies like the US FDA (DSCSA) and EU FMD. Aggregation is no longer optional, it’s becoming essential.

With the rise of counterfeit medicines, online distribution, and globalized supply chains, governments require manufacturers to implement serialization and aggregation for full traceability.

Aggregation ensures:

Patient safety through full supply chain visibility
Compliance with current and future regulations
Rapid, accurate recall processes
Protection of brand integrity and market access

Serialization and Aggregation in Pharma

Benefits of Serialization and Aggregation in Pharma

Pharmaceutical companies implementing serialization and aggregation gain operational, financial, and compliance advantages:

Regulatory readiness across markets
Supply chain optimization with real-time tracking
Simplified returns and recall processes
Reduction in manual errors and duplicate serials
Data-driven insights to improve efficiency
Decommissioning of pallets and cases made easy
Increase in supply chain security and efficiency

Typical Challenge

Typical Challenge

From Pain Points to Best Practices

Disruption to current workflows
Financial impact of post-serialization integration
Operator training and learning curves
Temporary reduction in line productivity
Pressure to meet fast-approaching compliance deadlines

Benefits

How We Solve Pharma Aggregation Challenges

Minimal downtime solutions with easy changeovers
Tailored training and onboarding support
Deep integration experience with existing IT, MES, and ERP systems
Turnkey solutions that reduce complexity and risk
End-to-end project management to ensure fast, compliant deployment

FLY_OPTEL_Industry_Pharma_EN_TIMG_500x500

Turnkey Track & Trace Solution

WHY CHOOSE OPTEL?

Turnkey, Fully Integrated Systems
Integration Expertise from L1-L5
Transparent Pricing and Scalable Options
Flexible, No-Lock-In Architecture
24/7 Local Support Team

SUCCESS STORIES

Tailor made solution compliance

Flexible and Tailor-Made Solutions to Ensure Compliance

galderma

How Galderma Plans on Going Beyond Compliance

FAQs on Aggregation in Pharma

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