TraceLink, the world’s largest track and trace network for connecting the Life Sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace, has announced that Ropack Pharma Solutions has selected TraceLink to provide serialisation solutions for its customers.
Leveraging the TraceLink Life Sciences Cloud, Ropack’s international serialisation hub provides an efficient and streamlined solution to assist its 130+ pharmaceutical manufacturing customers prepare for the rapidly approaching serialisation deadline in November 2017 to comply with the US Drug Supply Chain Security Act (DSCSA).
Ropack Pharma Solutions is a leading contract development and manufacturing organisation (CDMO) that brings solid oral dosage packaging solutions to the top pharmaceutical and natural health organisations throughout Canada and the United States.
The Ropack international serialisation hub enables packaged pharmaceutical products to be sent by an organisation’s in-house packaging team or contract partners to the Ropack facility. Using the TraceLink Life Sciences Cloud and Optel Vision, the packaged products are serialised, aggregated and then shipped with the appropriate complication documentation, to a distribution network or another warehouse.
“Serialisation and regulatory compliance are complex process, but with TraceLink, it’s a simple connection that is low cost and managed entirely by their in-house experts. We selected TraceLink because it offers an easy-to-use platform that helps our customers achieve compliance without all the challenges and difficulties that pharmaceutical manufacturers often face when implementing a serialization programme,” said Paul DuPont, Vice President of Marketing and Business Development, Ropack.
“Becoming serialisation ready for DSCSA is a complicated, time-consuming and costly endeavour for all companies, large and small. Our international serialisation hub, leveraging the TraceLink Life Sciences Cloud as a core component, reduces an organisation’s capital expenditures, need for increased personnel and the multifaceted coordination required for serialisation.”
“Time is crucial with the first DSCSA serialisation deadline going into effect later this year. Companies ultimately need to master the complex DSCSA requirements, implement their solution to generate, store and manage unprecedented volumes of regulated data, and exchange that data with all of their supply chain partners. Complying with serialization is a daunting task that takes time, money and resources, and for companies that haven’t started yet, being ready by November 2017 may be unattainable,” said Shabbir Dahod, president and CEO of TraceLink.
“TraceLink lifts all of these burdensome tasks and partners with Ropack to offer an efficient and practical alternative to companies looking to outsource their serialisation programmes.”
With more than 500 life sciences customers and over 246,000 trading partners on the Life Sciences Cloud network, TraceLink provides an end-to-end compliance solution for the pharmaceutical supply chain. Customers integrate once and immediately interoperate with all of their trade partners to securely exchange regulatory data and cost-effectively comply with track and trace requirements.
To learn more about meeting global or country-specific pharmaceutical compliance deadlines and how to build a flexible serialisation, track and trace, and reporting platform for the US, the EU, China, Brazil, South Korea, India, Turkey, Argentina and other countries, please visit www.tracelink.com.