2 Billion Pharmaceutical Products Protected from Counterfeiting and Diversion with TraceLink E-Pedigree

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TraceLink's E-Pedigree has now protected over 2 billion pharmaceutical products from counterfeiting and diversion since its release in 2006. New Life Science customers such as KLE 2 Inc. join over 50 companies who rely on E-Pedigree to help them safeguard patient safety from threats such as the recent Avastin counterfeiting issue, secure nationwide regulatory compliance and ensure drug product availability.

TraceLink Inc.

Securely Supply Every Global Market Opportunity On-Time and In-Full

In less than a week, we went from initial proposal to live pedigree system. TraceLink E-Pedigree gives us an affordable solution that helps us compete on a level playing field with larger pharmaceutical companies. - KLE 2 Inc.

TraceLink, Inc., developer of the TraceLink Network, a cloud-based software platform helping companies securely supply every global market opportunity on-time and in-full, today announced that its E-Pedigree product has reached the milestone of securing its two billionth drug product from the threat of counterfeiting and diversion. Launched in 2006, TraceLink E-Pedigree is currently used by over 50 Life Science companies, wholesale distributors and pharmacies to safeguard patient safety and efficiently ensure nationwide regulatory compliance including all state-level ePedigree regulations for places such as Florida and Nevada.

“Providing software tools to help pharmaceutical companies and their distribution partners safeguard patient safety and ensure drug products are available in all markets regardless of regulatory requirements is critical,” said Shabbir Dahod, president and CEO of TraceLink. “Counterfeiting incidents such as the Avastin issue and product quality issues such as the Heparin incident highlight the ongoing need for better visibility and traceability throughout the pharmaceutical supply chain.”

TraceLink E-Pedigree provides numerous benefits to companies large and small:

  •     Flexible Pedigree Management. Receive, create and send electronic pedigrees. Capture or send paper pedigrees. Provide a pedigree portal to customers. All in the same solution.
  •     Extensive Operational Support. Ensure support for current and future business operations through dozens of built-in use cases for product receiving, shipping, repackaging, kitting and more.
  •     Automated and Manual Operation. Directly integrate to internal ERP, SCM and inventory management systems or use as a standalone solution through our efficient user interface.
  •     Minimized IT Burden. Hosted, turnkey solution means startup in days not months and minimal IT costs.

“We are a small but quickly growing pharmaceutical company and we needed an ePedigree system that was easy to use, fit our operational and distribution requirements and was live on a very tight timeline,” said Kevin Laxer, president and CEO of KLE 2, Inc. “In less than a week, we went from initial proposal to live pedigree system. TraceLink E-Pedigree gives us an affordable solution that helps us compete on a level playing field with larger pharmaceutical companies.”

Ensuring a safe and secure pharmaceutical supply chain is a topic of growing discussion throughout the industry. Recently published articles (such as “Manufacturers are reviving their serialization plans”, Pharmaceutical Commerce 02/22/12) suggest that regulatory activity on a federal level may be increasing. This includes the potential for attaching pedigree, serialization and traceability language from bills such as the Matheson-Bilbray legislation currently before the U.S. Congress to the expected Prescription Drug User Fee Act (PDUFA) reauthorization.

TraceLink’s Track and Trace solutions for global pedigree, serialization and traceability requirements are designed to ensure complete compliance with current and emerging track and trace mandates. These solutions include:

  •     Product Track. Securely track serialized product throughout the supply chain using GS1 EPCIS standards
  •     Government Reporting. Implement diverse global and country-specific (India, Turkey, etc.) governmental reporting requirements on products with a single solution
  •     Product Authentication. Mobile (iPhone, Android and SMS) and enterprise product identity verification for channel partners, care givers and patients
  •     E-Pedigree. Maintain a secure chain of custody for tracing movement of drug products from point of manufacture to point of dispensation
  •     Serial Number Exchange. Manage product serial number provisioning and exchange between pharmaceutical companies and their CMO/CPO partners

To learn more about TraceLink’s cloud-based solutions for integrating the supply network, improving production visibility, reducing inventory levels, eliminating risk in the pharmaceutical quality review process and ensuring patient safety through pharmaceutical traceability and authentication, visit http://www.tracelink.com.

About TraceLink:
TraceLink helps companies securely supply every global market opportunity on-time and in-full through the TraceLink Network. The TraceLink Network is a cloud-based application that connects business transactions, partner networks and professional relationships across companies and functions. The result is improved visibility, predictability and performance across global manufacturing and supply chain operations. The TraceLink Network integrates a elastic cloud infrastructure, an “integrate-once, interoperate-with-everyone” transaction platform, user-managed business collaboration workspaces and integrated business process modules for outsourced production management, product traceability and other multi-enterprise supply chain operations.

TraceLink is funded by FirstMark Capital, a venture capital firm managing more than $2 billion in capital commitments. For more information on TraceLink and our solutions, visit http://www.tracelink.com.


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