Blue Sphere Health


Datamatrix The next few years will see major change in the pharmaceutical supply chain. Traceability and serialization is coming to almost all major markets. The Falsified Medicine Directive in the European Union, Drug Supply Chain Security Act in the USA, and many similar legislative and regulatory moves elsewhere will mean that all manufacturers, distributors and pharmacy chains need to think differently about their products. Tomorrow, drug makers will be producing not just physical inventory but virtual, invisible inventory in the form of pack-specific data. It is a revolution that goes well beyond printing codes on boxes and labels. This new, parallel asset will be every bit as valuable as the drug itself, since the physical products won’t be sellable without accurate accompanying data. If you are designing or reviewing your approach to traceability you need to think wider than simply coding and serialising packs. Data management, process control and many other related areas will change. This is a time-consuming, multi-department, business-critical, change management project. We can help you to design and implement a complete serialisation programme including identifying and stratifying the key risks and business drivers. We advise on technology choices and vendor selection. We can help with related functions such as artwork changes and pack design to accommodate new codes. We can support adjunct initiatives on master data management, migration to GS1 data structures, ensuring business partner readiness etc. Don’t try to cut corners on serialisation. Contact the experts at Bluesphere.

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Pharmaceutical Anti-Counterfeiting

Combating the Real Danger from Fake Drugs has become a must-have primer on anti-counterfeiting and is widely used by drug companies, regulators and others. The book covers the legal, strategic and political issues as well as the technical counter-measures such as process control, digital serialisation and physical security.

Pharmaceutical Anti-Counterfeiting book