IBI Lorenzini, an Italian-based company, is a company that operates both as a traditional pharmaceutical company and a contract manufacturing organisation (CMO).
It exports products to Europe and the US, meaning that it has to stay compliant with the forthcoming Falsified Medicines Directive (FMD) deadline, as well as the US Drug Supply Chain Security Act (DSCSA). In addition, the company also exports to 20 countries across five continents, necessitating guidance from TraceLink on its global ‘track and trace’ requirements.
The company is already ready for the upcoming DSCSA, which was pushed back by a year to allow companies more time to prepare for the changes. IBI Lorenzini revealed that it will aim to be prepared for the FMD requirements by the end of this year, ahead of the deadline in February 2019.
When asked why IBI Lorenzini chose its services over competitors, Tracelink’s spokesperson confirmed it was the range of solutions to varying regulations that provided the draw: “IBI Lorenzini selected TraceLink’s Life Sciences Cloud platform as it offered a serialization data management and exchange solution that would ensure on-time compliance with numerous regulations including the EU FMD’s February 2019 deadline.
“TraceLink’s network approach delivered the flexibility and scalability IBI needed to connect with its partners and customers as quickly and efficiently as possible, while providing a simple connection into the EU hub.”
The importance of being prepared
The Tracelink spokesperson highlighted just how far some companies still have to go to be ready for the serialization process; it revealed that when it had polled industry leaders, at its FutureLink event, a fifth of respondents had not yet selected a serialization partner.
When asked what this could mean for those leaving serialization preparations too late, the spokesperson responded: “The risk is simply that businesses may not be able to ship product in the EU if they are not compliant with the regulation.
“Over a fifth (22%) of poll respondents at FutureLink suggested that manufacturers were delaying preparations in hope that there would be an extended period for implementation.”
TraceLink has responded to this delayed uptake by extending the range of business it partners with on the serialization services, such as aiming to provide solutions to smaller business.
A growing market
Breaking at the same time as the partnership news was a report, produced by ReportsnReports, which estimates that the global track and trace solutions market is set to more than double to be worth $3.93bn (€3.4bn). This represents a compound annual growth rate of 18.9%.
The report suggested that the reasons behind this high growth are the demands of global serialization, more of a focus being placed on brand protection of products, general growth across medical devices and the pharma industries, and an increased number of packaging-related product recalls.