Ropack Pharma Solutions is a contract development and manufacturing organization that supports solid oral dosage projects from early-stage formulation through clinical manufacturing, packaging, distribution and commercial manufacturing and packaging stages.
The company recently selected TraceLink’s serialization solutions for its customers. Using TraceLink Life Sciences Cloud, Ropack's international serialization hub provides an efficient and streamlined method to assist its 130+ pharmaceutical manufacturing customers as they prepare for the rapidly approaching Nov. 2017 serialization deadline to comply with the U.S. Drug Supply Chain Security Act (DSCSA).
Ropak’s hub enables packaged pharmaceutical products to be sent by an organization'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 serialized, aggregated and then shipped with the appropriate complication documentation to a distribution network or another warehouse.
“Serialization and regulatory compliance are complex processes, 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 program,” says Paul Dupont, Vice President of Marketing and Business Development, Ropack.
“Becoming serialization-ready for DSCSA is a complicated, time-consuming and costly endeavor for all companies, large and small. Our international serialization hub, leveraging the TraceLink Life Sciences Cloud as a core component, reduces an organization's capital expenditures, need for increased personnel and the multifaceted coordination required for serialization,” he adds.
“Time is crucial with the first DSCSA serialization deadline going into effect later this year,” notes Shabbir Dahod, President and CEO of TraceLink. “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. TraceLink lifts all of these burdensome tasks and partners with Ropack to offer an efficient and practical alternative to companies looking to outsource their serialization programs."