Pharma Companies

Pharmaceutical Serialization Regulatory Challenges

Global complexities

Pharmaceutical companies are where it all begins, so it’s not surprising that you are the only supply chain segment with a requirement in every country that has announced compliance laws. And since no two countries have adopted the same ones, you face the challenge of having to satisfy many disparate mandates if you operate internationally.

How can you implement so that you have one pharma track and trace solution that meets all market needs, rather than point-to-point solutions for every country? How do you manage all these differences when as much as possible, you want your processes to be the same in order to achieve efficiencies and predictability?

The first step is to architect a global serialization track and trace platform that can help you turn all of the differences into commonality. That’s the core challenge for companies to address. You need to be able to manage and interact with your serial numbers in the same way, whether you’re operating in Brazil with their custom format, or in China where you must request your numbers from the government. You need to be able to reliably report required data, whether it’s to trade partners or government entities, and regardless of the required format.

Supply chain partnerships

Today, most pharmaceutical companies outsource fifty to one hundred percent of their manufacturing to contract manufacturers. In order to be successful with pharmaceutical serialization, you need to have these service providers – both CMOs and packagers -- establish serialization technologies and processes. That complicates the implementation time because there are business relationships to establish and technical connections to achieve.

And with these outsourced processes in play, you must have an efficient collaboration model so all companies can integrate and exchange information. As a pharmaceutical company, you likely have up to  hundreds of contract manufacturers. And your CMOs are working with tens to hundreds of pharmaceutical companies, as well. Point-to-point integrations with so many partners are just not possible. You need to establish an integrated environment for seamless communications. 

How TraceLink Can Help

The TraceLink Life Sciences Cloud takes all the market discrepancies that come with compliance and effectively neutralizes them. We manage the differences, providing one platform that helps you navigate each country’s requirements and produce the data they want in the format they specify. We monitor the regulations, too, and update our platform to meet evolving compliance needs.

The TraceLink network allows you to integrate once, and then interoperate with many. Our team onboards your company to the network and all of your trading partners, too, even if they are not TraceLink customers. You can then seamlessly communicate with all of them, exchanging the data required for compliance. The network simplifies the regulatory technical demands, but it also provides a platform for efficient business relationships.

Read our recently published article, The Life Sciences Supply Chain and Serialization: Three Emerging Trends, which covers three current trends that will help drive solution strategies and key decisions for your business.

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