Press Releases

Virtus Pharmaceuticals Leads the Way in DSCSA Compliance with TraceLink

November 4, 2014

TraceLink Inc., the leader in protecting patient safety and enabling health for global Life Sciences, announced today that Virtus Pharmaceuticals, a specialty niche pharmaceutical company focusing on hard to manufacture and deliver drugs, has chosen the TraceLink Life Sciences Cloud and Product Track to ensure supply chain security and compliance with the impending US Drug Supply Chain Security Act (DSCSA) deadline of January 1, 2015.

“With the January 1 deadline quickly approaching, we needed a partner with the expertise to address the additional DSCSA complexities facing our organization, which has both manufacturing and wholesale distribution regulation requirements due to our business structure,” said Louis Sanchez, CEO of Virtus Pharmaceuticals. “TraceLink provided us a deep level of education of the regulation and its implications on our business operations, helping Virtus to create a secure DSCSA compliance plan. And because we can leverage the TraceLink network that includes thousands of manufacturers, wholesalers and pharmacies already configured, we can connect to our entire ecosystem of supply and trading partners through a single network connection, eliminating the cumbersome challenge of creating separate integrated links between us and every one of our partners.”

“As a trailblazer in the industry, Virtus looked to get an early start on DSCSA compliance given the complexities of the law,” said Shabbir Dahod, president and CEO of TraceLink. “TraceLink’s Transaction History Management System provided the built-in operational flexibility that Virtus needed and the plug-and-play trading partner network that minimized Virtus’ risk in meeting the January 1 DSCSA deadline.”

DSCSA regulations require companies to trace and verify products and transactions across all changes of ownership with all suppliers and trading partners from manufacturer to dispenser. A company like Virtus that both manufactures and distributes medicines to wholesale distributors and pharmacy chains faces considerable data management and business process challenges under DSCSA. TraceLink Product Track was developed specifically to minimize such complexity and ensure operationally efficient compliance for all companies from $10B life science companies to $500K wholesale distributors and independent pharmacies.

The TraceLink Life Sciences Cloud: A Unique Platform for Ensured DSCSA Compliance

A single connection to the Life Sciences Cloud delivers end-to-end DSCSA compliance for all DSCSA requirements of the largest pharmaceutical company or the smallest pharmacy across all supplier and trading partner relationships. In fact, companies like Virtus who work with TraceLink to help them meet January 1, 2015 DSCSA deadlines typically find that over 90% of the suppliers and trading partners they do business with are already on the TraceLink network from day one.

Built on the Amazon Web Services global cloud infrastructure as a native cloud application platform, the TraceLink Life Science Cloud delivers a complete DSCSA compliance solution for all Tracing, Verification and Serialization requirements including:

  • A full Transaction History Management System including integrated tracing and verification support for both lot-level and serialized products in a fully indexed compliance document repository
  • Extensive interoperability across the entire supply network with support for HDMA ASN, GS1 EPCIS and secure web portal
  • Extensive operational use case support for manufacturers, wholesalers and pharmacy chains to support efficient receiving, putaway, and pick-pack-ship operations
  • Complete management of all DSCSA compliance scenarios including direct purchase and non-direct purchase, drop shipment, saleable returns and other special TH/TI/TS requirements

For more information about meeting critical DSCSA compliance deadlines or building a flexible global serialization, track and trace, and reporting platform for China to Brazil, visit www.tracelink.com.

About TraceLink

TraceLink protects patients, enables health and ensures compliance for companies across the global Life Sciences supply network, including fourteen of the top-20 global pharmaceutical companies. Leading businesses trust the TraceLink Life Sciences Cloud, our Amazon AWS-based cloud application platform, to deliver complete global connectivity, visibility and traceability of pharmaceuticals from ingredient to patient. A single point and click connection to the Life Sciences Cloud creates a supply chain control tower that delivers the information, insight and collaboration needed to improve performance and reduce risk across global supply, manufacturing and distribution operations. Winner of numerous industry awards including the Amazon AWS Global Start-Up Challenge Grand Prize and the Edison Award for Innovation in Health Management, the TraceLink Life Sciences Cloud is used by businesses across the globe to meet strategic goals in ensuring global compliance, fighting drug counterfeiting, improving on-time and in-full delivery, protecting product quality and reducing operational cost. For more information on TraceLink and our solutions, visit www.tracelink.com.

TraceLink is funded by FirstMark Capital. FirstMark Capital is an early stage venture capital firm based in New York City. FirstMark’s mission is to partner with exceptional entrepreneurs who are changing the world by solving meaningful problems. FirstMark has built a deeply engaged community among the extraordinary teams in the FirstMark network to spread ideas and opportunities. FirstMark is privileged to work alongside the founders of remarkable businesses like Pinterest, Lumosity, Aereo, TapAd, Shopify, Riot Games, and dozens more. Visit FirstMark in New York City or online at firstmarkcap.com and @FirstMarkCap.



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