EU FMD Express: The Perfect Partner for Virtual Pharma
For this virtual pharma company based in France, supply chain connectivity was vital to meeting the EU FMD requirements. With all of its manufacturing outsourced to CMOs, it needed an efficient way of generating and exchanging serialization data with its partners by February 2019. With just 8 months to the deadline, the company engaged three solution providers with the goal of selecting the one best suited to:
- Help it meet the EU FMD deadline with minimal disruption
As a small company without internal resources to dedicate to the project, it needed an easy-to-implement solution, from an established provider that offered local support and expertise. Given the tight timeframe, the company also wanted to minimize risk of delays—or even failure—by choosing a proven solution provider.
- Integrate its virtual supply chain model
The company counted on a network of CMOs and 3PLs to handle all its manufacturing and
distribution,and needed a solution that would allow its entire partner network to exchange data on orders, recalls, and more.
- Provide references from companies like them
It was essential that the chosen provider understood the needs of a virtual company, and could demonstrate successful serialization projects for other small, virtual customers.
Decision driver: References highlight a proven solution with seamless deployment
The company concluded that two of the solution providers they were evaluating—while able to propose attractive pricing—could not meet these basic needs. It chose TraceLink for its ability to offer:
- A cost-effective, off-the-shelf solution for rapid implementation
TraceLink’s solution for smaller pharma companies, EU FMD Express, provided proven functionality with fast, expert deployment at a low cost. With little time and limited resources, the pharma company saw the advantages of a robust off-the-shelf solution that included deployment, testing, and training services.
- A network model for end-to-end supply chain connectivity
TraceLink’s analysis of the pharma company’s supply chain showed that 3 of the 4 company’s CMOs were already on the TraceLink network. With one connection to TraceLink, the company could connect to all of them, eliminating the time and resources required to develop individual connections.
- A proven record with similar companies
TraceLink provided references from small and virtual pharma customers. With over 190 customers in Europe alone, TraceLink is proven to deliver on EU FMD compliance, and as of June 2018 had already helped 34 companies complete EMVO’s new conformance tests. TraceLink’s Europe-based implementation and services teams offered native-language support during and after deployment, to ensure a smooth implementation and business continuity.
EU FMD Express: turnkey compliance for smaller pharma companies
By choosing TraceLink, this virtual pharma company is on track to achieve EU FMD compliance by the February 2019 deadline. EU FMD Express uses the same proven technology as TraceLink’s enterprise-level EU FMD Compliance solution, while offering the streamlined configuration smaller companies need. And being part of the TraceLink Life Sciences Cloud will simplify the onboarding of additional supply chain partners if the pharma company chooses to expand.
Contact us to learn how we can help companies—large and small—meet their compliance and supply chain management needs.