i2b provides a complete service to satisfy the various needs required by the everchanging traceability regulations
Serialisation is the process of assigning and applying a unique identification code to a product during its packaging process. Aggregation defines the relationship between multiple items within a container, such as blisters, cartons, bundles, cases, and pallets.
The life science industry – including pharmaceutical, biotechnology, medical product, technology, and device companies – is currently focused on preparing itself for the future so as to stay in compliance and increase product safety. Serialisation has become a major subject among the pharma industry and the regulatory agencies in many countries, mainly due to the increasing counterfeit occurrences and its high risks to the consumers and patient’s health. High concerns and consequent commitment from the government on this subject caused the publication of many new regulations in the past years - and more are to come. The lack of knowledge in general and the practical experience of the market on this subject - industry, wholesalers, suppliers, public and private entities, etc. - make this subject a huge challenge and full of open questions and doubts to clarify. There is an urgent need to prepare strategies and to implement actions with challenging deadlines, to cover these new and future requirements, to be in compliance and to receive the benefits from these regulations. Also a challenge is the differences of the many regulations, the high complexity of the whole serialisation and T&T process, in many different areas such as shop floor equipment for manufacturing facilities, quality systems, supply chain, regulatory affairs, information systems and many more.
Having a thorough experience on this subject and having implemented various projects, i2B experts can help your Company to understand the main reasons, current status and key regulations of the Serialization and Track & Trace (T&T) Worldwide and the impact on the industry, suppliers, entities, regulatory agencies short, mid and long term. Furthermore we will assist you on understanding Serialization and T&T in the whole production and supply chain and assess the current available technologies for serialisation / T&T and trends. Ι2B experts will help you to define strategies to supply and/or implement serialization and T&T, considering technical, management and regulatory aspects, understand the risks and the impact to existing processes, allowing proactive preparation and application of corrective measures.
get in touch with.
Fotios Angourakis / Head of T&T
P.: +41 (0) 71 667 05 43
85 Gounari & 1 Gortynias street
165 61 Glyfada/Athens
P: +30 (0) 210 960 15 29