Press Releases

TraceLink Discusses Global Serialization at Pharma & Biopharma Outsourcing Association (PBOA)

March 30, 2015

TraceLink Inc., the leader in protecting patient safety and enabling health for global Life Sciences, announced today that Graham Clark, TraceLink’s CMO/CPO Partnership Manager, will speak on global pharmaceutical serialization and the challenges for contract manufacturing and packaging companies at the Pharma and Biopharma Outsourcing Association’s Regulatory/Legislative Workshop on March 30 in Washington DC. TraceLink is also pleased to announce that it has joined the Association to work with its members on meeting global track and trace regulations and helping improve business performance across the entire outsourced manufacturing lifecycle.

"We're happy to have TraceLink aboard as an Affiliate Member of the Pharma & Biopharma Outsourcing Association," said Gil Roth, president of the PBOA. "As the CMO/CDMO sector has grown in importance and new serialization regulations roll out in different countries, it's critical that our member companies stay on top of the technologies and services available to assure the safety of the drug supply chain. TraceLink’s long standing relationship with leading CMOs and years of experience helping build solutions in this space will provide a great service to our members."

"TraceLink is very excited to join the Pharma & Biopharma Outsourcing Association," said Shabbir Dahod, president and CEO of TraceLink. "The CMO/CDMO sector has become a strategically important part of the life sciences supply network. As a result, outsourced supply partners now face significant challenges in meeting diverse pharmaceutical customer requirements, ensuring quality and performance in external supply operations and preparing for continuously evolving global serialization regulations. We’re pleased to work with PBOA and its membership to develop solutions for these key issues."

Global track and trace regulations incorporating the serialization, traceability and verification of pharmaceuticals will impact over 75 percent of the global drug supply by the end of 2018. Serialization and traceability readiness is now a strategic business requirement for the pharmaceutical industry and CMO / CPO companies play a key role in the production of over 40 percent of all medicines produced. Ensuring serialization readiness across this crucial external supply relationship has been a key focus for TraceLink. Read the five reasons to discuss serialization now for pharmaceutical companies and their contract partners.

Joined at the Workshop by key thought leaders from the FDA, PDA, PharmSource and Arnall Golden Gregory, Mr. Clark will lead an interactive discussion with PBOA members on key serialization issues including:

  • The diverse and evolving global serialization compliance environment facing CMO/CPOs;
  • Key learnings from global serialization implementations across design, planning and deployment;
  • The crucial operational, supply chain and IT issues to consider in crafting a harmonized serialization program;
  • Core questions to address in bringing together the pharmaceutical customer and the external supply partner.

TraceLink’s TraceLink Life Sciences Cloud, global track and trace applications and interconnected network of over 124,000 supply network entities are trusted by fifteen of the top 20 global pharmaceutical companies and businesses across the global supply chain from pharma manufacturer to pharmacy dispenser to meet serialization, traceability, reporting and other track and trace compliance requirements.

To learn more about meeting global pharmaceutical compliance deadlines designed to combat drug counterfeiting, and how to build a flexible global serialization, track and trace, and reporting platform for the US, European Union, Brazil, China and other countries, visit www.tracelink.com.



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