CMOs and CPOs

Serialization Regulatory Challenges for CMO/CPOs

Contract manufacturers and packagers play a critical yet challenging role in the supply chain. With many pharmaceutical companies outsourcing a large percentage of their production, the majority of today’s prescription drugs flow through your hands. 

Because of that, you will be heavily impacted by upcoming serialization requirements. But since your pharmaceutical customers own the products and bear legal responsibility for compliance, you must collaborate closely with them to understand their exact serialization needs, negotiate financial responsibility for both dedicated and shared line upgrades, and schedule all those equipment overhauls well in advance of the November 2017 DSCSA and other serialization deadlines. Your success in properly preparing for upgrades hinges on starting early, yet you are heavily dependent on pharmaceutical companies to get the ball rolling.

Line upgrades are a priority, but selecting a system to manage data exchange with your partners is equally important. It’s also one task you can check off your list without having to wait for pharmaceutical partners’ input. How will you pass serialization information back and forth? Given the large number of customers you work with and the unprecedented volume of data that serialization will introduce, identifying the right system architecture is a critical task.

How TraceLink can help

The TraceLink Life Sciences Cloud provides one platform where you can seamlessly connect with all of your customers. Sixteen of the top 20 pharmaceuticals are already on our network, and many of your other partners likely are, as well. With the TraceLink Cloud, one simple connection to the network allows you to then interoperate with everyone on it, eliminating the need for dozens to hundreds of time-consuming and costly point-to-point connections.

You have a long and complex list of preparatory tasks to address for serialization. Simplify the communications piece by choosing the industry leading solution, where the life sciences supply chain community comes together.
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