Serialization means the application of a unique random serial number on each saleable unit of pharmaceutical product, which can be traced back to the original source of supply. Serialization is used to tackle the risk of counterfeit and adulterated drugs, medicines and other health products. National authorities have pursued the need for product serialization. A complete serialization program represents the complete history of a given product's chain of custody from the manufacturer to the point of distributing.

Having a thorough experience on this subject and having implemented various projects, i2b Serialization 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 serialization / 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.

We recognize that Serialization requires attention from almost every department in your organization: legal, IT, sales/marketing, sourcing, supply chain, quality, regulatory, and manufacturing. I2b Project approach is based on Agile methodology which ensures the coordination of all multiple functions from Labelling to Product supply. The change management and training of new processes are also important factors of Serialization project success.