Pharmaceutical companies of different sizes face different challenges. However, large companies generally have more financial resources than small companies. Differences arise not only in terms of research and development but also in dealing with regulations. While research and development are usually core areas of pharmaceutical companies, dealing with global regulations is seen as a necessity. In the complex field of regulations, pharmaceutical serialization especially is often neglected. As a result, it represents a more significant obstacle for small companies than large corporations due to their limited resources. The possibility of outsourcing the entire serialization process would be an ideal means of overcoming this obstacle.
The respective serialization requirements of the markets are an essential part of global regulations. Although the European Falsified Medicines Directive (EU-FMD) covers a large part of the European market, the worldwide legislation is inconsistent. In addition, there are regular changes and the introduction of new serialization requirements in countries that do not yet have track & trace systems. Small marketing authorization holders (MAHs) are facing challenges as a result, particularly with regard to serialization.
What challenges do small pharmaceutical companies face?
One obvious difference between small and large companies is the number of employees. This difference creates challenges large companies have fewer points of contact with. In our experience, unfortunately, in the serialization for small MAHs it is common not to have a dedicated person or department. Instead, people take on these tasks on the side, in addition to their core competencies. In some small companies, the CEOs even have to take on this additional task when in doubt. The result: serialization management is often treated as a minor issue.
In addition, small MAHs sometimes produce irregularly. Therefore, it is hard to develop a routine for the serialization process. The result is errors and lost time. Serialization should not be considered lightly, as it involves compliance with regulations in different markets. Regardless of the responsibility, it is inevitably neglected. Subsequently, a reliable partner for serialization is crucial.
How can tracekey help?
At tracekey, we have always specialized in small and medium-sized companies and know what obstacles they face. That’s why we also know how to overcome these obstacles. For this purpose, we have established the tracekey Serialization Manager (TKSM) service, adapted to the needs of SMEs. TKSM is our version of business process outsourcing. We take care of all your pharmaceutical serialization needs. Be it the creation of reports for the authorities, the management of product master data, or the serialization process itself. If required, we can handle the entire serialization, but modularization is also possible. You can also hand over communication with your business partners (CMO) to us. For example, we take care of onboarding CMOs for new target markets or any tasks that arise during production.
You are enabled to concentrate on your core business. Tracekey takes over the responsibility for the management of CMOs and troubleshooting. Even if you are not yet a tracekey customer, we can do the work for you. We are happy to support you with alert management. With regard to the current changes (AMS system), it is to be expected that these will gain a lot of attention from EMVO in the near future.