When the Drug Supply Chain and Security Act (DSCSA) was passed in 2013, the task, i.e. serialization, set forth for pharmaceutical manufacturers seemed herculean at best. Institutionalizing the ability to trace your product across the supply chain – a supply chain that is increasingly expanding and adding new touchpoints – is clearly no simple task.
This particular client, as one of the larger drug manufacturers in the world, was especially aware of the challenges that lay ahead. With locations spanning Europe, North America, South America, Asia, and Oceania, the client needed a serialization program that leveraged industry best practices while meeting site-specific regulatory requirements.
Through a collaborative process, I’m happy to say that we were able to work with the client to:
- develop a strategy to serve as a guide for all future serialization projects,
- implement new processes and rework existing ones to accommodate serialization requirements with little-no impact to efficiency,
- integrate serialization initiatives across multiple locations for a seamless and global serialization program, and
- meet and maintain full compliance with all legal requirements.
Not only was the client fully serialized well before the regulatory deadlines but they also gained recognition as a leader in serialization before many of their industry peers. The success of the project can be attributed primarily to the client entering the initiative prepared to delegate the time, resources, and responsibilities necessary for a project of this scale. Paired with Clarkston Consulting’s team of industry-leading serialization experts, the success of the project was all but certain.
The following case study provides a high-level view, including the initial objectives, tasks, resolutions, and benefits associated with the project. If you’re interested in learning more about this engagement or any of our other serialization work, please contact me at firstname.lastname@example.org. If you’re interested in learning more about serialization, be sure to check out our serialization insights.