Food Supplements – Serialization in Russia

Food Supplements Russia

Chestny ZNAK is the track andtrace system for the Russian market. Apart from pharmaceuticals, it ensures the security of the supply chain of many other goods. These goods include tobacco products, beer, medical devices, and food supplements. Counterfeit protection is expanding to fields other than pharmaceuticals, as Russia’s markets are particularly affected by counterfeiting. According […]

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Product Safety in Pharma & MedTech

product safety pharma

In the European Union, medicinal products and medical devices are only approved for the market if manufacturers can guarantee the safety of their products. If adverse events occur after the products have been placed on the market, the vigilance procedures of the respective industries take effect. This is because patient safety continues to be a […]

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Despite comprehensive preclinical and clinical studies, it is not uncommon for drug risks to be discovered only after market approval. Possible reasons are a larger patient population, multi-medication, off-label use, or medication errors. The pharmacovigilance department has the important task of identifying, assessing, better understanding and, if necessary, reporting these risks. In this way, a […]

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BPO Example: Alert Management System

Alert Management System

Earlier this year, the European Medicines Verification Organization (EMVO) released its new Alert Management System (AMS) portal to improve the exchange of information between stakeholders in the event of suspected counterfeiting. In addition, the initiated investigations can be tracked and logged more easily with the help of this portal. Due to the pan-European approach of […]

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Skills Shortage in the Pharma Industry – How We Can Help

Skills shortage in pharma

In many industries, there is a lack of skilled workers. It means that there are more vacancies than qualified people to fill them. Demographic change, digitalization, and the increasing professionalization of the labor market are often cited as the cause. Many potential employees are simply not sufficiently trained to meet the requirements of the advertised […]

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Agile meets Post-Market Surveillance

Agile meets Post-Marketing Surveillance

Medical device manufacturers are required by the MDR/IVDR to monitor the safety of their products even after they have been approved and have entered the market. This process is called Post-Market Surveillance (PMS) or Post-Marketing Surveillance. Due to the considerable amount of work involved, it can be advantageous to outsource this process to other companies. […]

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