Blue Sphere Health



Bluesphere’s founder literally wrote the book on pharmaceutical anti-counterfeiting. You can purchase a copy of “Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs” on this site. It has been used as a reference text by regulators and drug companies and is used in several pharmacy and medical school teaching programmes. If you are designing or reviewing your strategy for brand protection you need to think wider than just complying with mandatory requirements like coding and serialisation. We can help you to map existing processes and gaps and then design and implement a complete programme including identifying and stratifying the key risks and business drivers. We advise on technology choices and vendor selection, and help you acquire technology that works for you. Conversely, we often work with technology solution providers to develop their product positioning and sales messages. We can help with related functions such as process mapping and gap analysis, artwork changes and pack design, master data management and so on.

Hidden Challenges of New Regulations

Many companies do not yet realise that there are stringent reporting obligations embedded in new laws such as the Falsified Medicines Directive in the European Union and the Drug Supply Chain Security Act in the USA. The headlines have been around serialisation, traceability and (in the EU) tamper-evidence. Less reported have been the new requirements to identify suspect counterfeits and notify the authorities within very short timeframes (“immediately” or “within one business day”). This means that all brand owners need to have robust systems and procedures to capture, process and report counterfeiting and diversion incidents. Spreadsheets, email, and the implicit, unwritten knowledge of individuals are no longer good enough. You need software that is built for the task.

Software + Consulting

You need to be very efficient to keep regulators happy and to stay ahead of the counterfeiters. The answer is to automate tasks wherever possible. As a busy professional, you want to spend your time on value-added tasks that protect your brands, not on manually cataloguing a diverse flow of unstructured information. Our secure Knowledge Capture suite, supplied in partnership with Integritie, is used by major global brand owners such as Procter & Gamble to manage threats to their thousands of brands. Incorporating tools such as IBM’s I2 visualisation engine, it can be hosted in a secure cloud or at your premises. We have extended the capabilities of Knowledge Capture by adding our own TraqPaq mobile reporting tool for iOS and Android phones. The customised suite of solutions lets you bring multiple information flows into one dashboard.

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Adding more knowledge is only one step towards insight. With our decades of experience, we can help you use the data to plan your strategy and tactics. Our unique combination of software and consulting helps you react to today’s challenges and plan for tomorrow’s.

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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