Rethinking Serialization: Why Now is the Time to Close Know-How Gaps and How MSK Delivers Real Value

Seven years after the launch of serialization in Europe (EU FMD), it has become part of daily operations. However, everyday knowledge is eroding: projects are closed, teams have changed, and systems have been migrated. What remains is a gap between being “somehow compliant” and being “value-adding.”

This is exactly where MSK steps in – providing comprehensive Track & Trace and operational excellence down to the individual serial number level.

Seven Years After EU FMD: The Hidden Loss of Expertise

Team Turnover & System Changes:

The original project teams are often no longer in place. New colleagues inherit fragmented documentation, historical decisions can no longer be explained, and exceptions have become the standard.

Complexity in Daily Business:

Relabeling, export decommissioning, returns verification, batch splits, GTIN or NTIN? Many tasks are handled “the way they’ve always been done,” but are not fully optimized.

Data That Doesn’t Work:

Serial numbers are maintained but rarely used operationally – for example, in picking, channel monitoring, or root cause analysis for inventory value losses.

The Opportunity:

Those who bundle expertise now, realign processes, and actively use serialization data in operations will gain speed, transparency, and security.

Why Small Pharma Manufacturers Specifically Benefit from MSK

• Zero CapEx, Full Impact: Instead of managing their own lines, IT stacks, and qualifications, smaller manufacturers receive serialization and logistics as an integrated service – scalable, audit-proof, and ready for immediate use.
• Faster Market Access: Whether it’s a launch, artwork update, or temporary demand, we bridge bottlenecks and peaks without startup delays. Over-labeling/relabeling, tamper evidence, repacking, and status changes run in validated workflows from the very first order. This allows you to focus entirely on your core business. We handle serialization and end-to-end Track & Trace so your team can focus on the products.
• Operational Use of Serial Numbers: MSK handles picking down to the individual serial number, not just by batch or carton. This reduces mispicks, enables precise partial quantities, and accelerates recalls.
• Grey Market Prevention Included: Using serial-number-based “movement data,” unofficial trade flows can be detected and stopped early. This protects price levels, distribution agreements, and brand value.
• Transparency in Inventory Value Losses: If discrepancies occur, we can verify in seconds whether the affected serial number is still active or has already been returned, decommissioned, destroyed, or exported. This creates clarity for balance sheets, insurance, and audits.

Value in Hospital Supply – Focusing on Patient Safety

• Serialization-level verification along the hospital supply chain reduces the risk of unsafe goods reaching the point of care. Anomalies are immediately blocked, documented, and tracked.
• Fast, Targeted Recalls: Instead of stopping entire batches “on suspicion,” affected serials can be identified, isolated, and decommissioned within minutes instead of hours. This saves resources and prevents unnecessary interruptions in therapy.
• Shortage, Expiry Management, and Picking Accuracy: Transparency down to the individual pack makes expiry risks visible early; stocks can be prioritized, redistributed, or written off in time. This is a tangible advantage, especially for critical medicines.
• Picking based on serial numbers reduces mix-ups, simplifies partial quantities, and increases throughput. Every movement leaves a verifiable record from goods receipt to dispensing. For our customers, this means fewer inquiries, fewer manual corrections, and less audit stress.

What MSK Does Differently and Why It Matters

We offer complete Track & Trace from a single source. We link serialization, logistics, and quality into one seamless service. From serial number generation to commissioning/decommissioning and final delivery, MSK uses data across departments instead of managing it in silos.

For us, serial numbers are a tool to simplify work, not just a proof of compliance. This allows us to handle picking at the serial number level, safely manage exceptions, effectively prevent grey markets, and uncover irregular distribution paths before they jeopardize prices and availability.

Typical Scenarios for Our Partners:

• Market Launches & Artwork Changes
• Tender Business
• Returns & Inventory Cleanup
• Recalls & Regulatory Requirements
• Special Hospital Supply

Conclusion

EU FMD laid the foundation, but business value only arises when serialization data comes to life in operations. With MSK, you can close seven-year-old know-how gaps, increase efficiency, and create a measurable advantage. This is a decisive factor, especially for small pharma manufacturers and in hospital supply. MSK offers complete Track & Trace, handles picking down to the single serial number, prevents grey markets, and helps clarify inventory losses. If serialization is to become a competitive advantage, now is the time.