Blue Sphere Health

Serialisation

Our customers need systems to comply with the Falsified Medicine Directive in the European Union, Drug Quality and Security Act in the USA, and many similar legislative and regulatory moves elsewhere.

US specialty biosimilars company

This is a virtual company using Contract Manufacturing Organizations but with a need to “control its own numbers”. We designed basic processes and procedures, advised on Level 4 serialization vendor selection and helped the company liaise with chosen vendor to generate a fit-for-purpose, right-sized solution for their needs.

Mid-sized French pharmaceutical company

We helped develop a comprehensive, multi-site User Requirement Specification (URS) document for their serialisation programme, bringing external perspective and expertise from two of our associates with “big pharma” serialisation experience.

Mid-sized Swiss pharmaceutical company

Our customer had line equipment that they didn’t want to replace and had new requirements for aggregation and e-pedigree. We helped them to specify end-of-line equipment and middleware that could link the line to their manufacturing execution system (MES).

Global equipment and software vendor

We advised on market positioning and key messages to enable an established company to grow their market share and build out their service offering.

Vendor selection support

We are currently advising several clients on technology choices and vendor selection. The USA and EU are now broadly aligned in their timelines for serialisation and the formats for data sharing are also not too divergent. But the deadlines are looming. Now is the time to get your pack coding strategy and tactics into shape.

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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