UNITAX Ramps Up Business Growth and Meets Compliance Deadlines Ahead of Time with TraceLink

UNITAX-Pharmalogistik (UNITAX) is a fully integrated contract manufacturing organization (CMO) focused on the entire value-chain of the pharmaceutical industry for manufacturers and wholesalers of medicine and medical products. Founded in 1991, UNITAX has become a market leader in manufacturing, transportation, storage, and order picking services. As the first German company in the pharmaceutical industry to receive the coveted Good Distribution Practice (GDP) certificate for meeting the strict guidelines of the European Union (EU), they have successfully based the company’s growth on high-quality supply-chain management practices.

UNITAX handles storage and logistics for more than 190 customers in the pharmaceutical industry in diverse markets and operates three locations in Germany, including its headquarters in Berlin. UNITAX also contract packages products for over 15 customers, producing approximately 40,000 packages per day.

Challenge: Managing Serialization Complexities While Ensuring Quality and Integrity

With the growing threat of counterfeit medicines entering the pharmaceutical supply chain, the EU passed the Falsified Medicines Directive (FMD), mandating the identification, management, and traceability of all drug products through serialization by February 2019. Serialization requires multiple inter-connected systems across manufacturers and supply partners to synchronize together, including network, enterprise, site-level, line/warehouse and device level systems.

Demonstrating a passionate commitment to staying constantly up to date on new developments in manufacturing and regulations, UNITAX ensures that everything that comes into contact with their customers’ products is carefully selected according to objective criteria – from the qualified employees and the means of transport, to the equipment and software.

In order to reflect its investment and dedication to high-quality manufacturing, as well as its customers’ growing needs, UNITAX required a vendor who would act as a true partner and work with them to ensure a timely and accurate implementation and rollout of a serialization solution. They also required a partner who could manage the complexities of 8.5 million packages annually, across different systems, customers and countries, all while having a strong understanding of safety and local standards, and providing a solution that could scale as the business grew and regulations changed.

Streamlined Connections to Customers With Scalability Now and For the Future

UNITAX considered three vendors, including local German-based solution providers, but ultimately chose TraceLink because of its unique network approach.

TraceLink’s Life Sciences Cloud provided UNITAX the ability to easily connect with its customers via a single connection, removing the time-consuming and costly effort of creating point-to-point connections for each customer. Through TraceLink's network, UNITAX was able to leverage the information maps, format interoperability, messaging choreography, and configurable workflows to speed up the connectivity process with their customers.

“We chose TraceLink because of their strong ability to partner with us and the fact that TraceLink’s Life Sciences Cloud let us move quickly while removing complexity and ensuring we can scale for the future. Their unique “connect once, reach many” approach made it easy for us to connect with all of our customers a lot more quickly and cost-effectively than if we had to develop individual integrations with all of our customers,” said Steven Reinhold, Head of Manufacturing, UNITAX

With the selection of TraceLink as its serialization solution provider, UNITAX is not only able to help its customers achieve EU FMD compliance by the deadline, but also has the ability to scale as its customer base grows or its current customers expand into additional markets.

Early Preparation with TraceLink Sees Long-Term Cost Savings and Competitive Advantage for UNITAX

Through its partnership with TraceLink, UNITAX plans to be ready for EU FMD ahead of the February 2019 deadline. Early preparation allowed UNITAX to push ahead many other CMOs, as well as identify new opportunities with pharmaceutical companies in need of CMOs that are prepared for the serialization requirements.

With the scalability and flexibility provided by TraceLink's network tenant architecture, UNITAX is able to accommodate its customers’ needs.

UNITAX was also able to leverage cost-savings through TraceLink’s network and its integrate once, interoperate with everyone™ approach. With TraceLink, UNITAX was able to avoid hidden integration costs and long implementation timelines that are often seen with on-premise software or single tenant solutions.

 “TraceLink is the perfect partner for us. They allowed us to meet the FMD serialization deadline ahead of the Feburary 2019 deadline and put us in a position to win new business," said Mr. Reinhold.