Life Sciences

Optimize and secure the flow of data throughout your pharma, biotech or medical device supply chain

To comply with global traceability regulations and improve supply chain efficiency, it’s essential to maintain tight control over, and visibility into, the data flows that drive your business interactions. Axway can help you meet these high-priority requirements with specialized solutions for the unique data exchange processes, security policies and governance capabilities mandated in the Life Sciences industry.

In addition to the main global regulatory bodies (FDA, EMA, and MHLW), the world’s top 20 pharmaceutical manufacturers, the majority of U.S retail drugstores, and all major U.S. healthcare wholesalers and distributors rely on Axway solutions to process more than $1.5B in transactions daily.

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If you need to... So your company can... Axway can help.
Comply with global traceability regulations
  • Reduce costs and complexity associated with complying with emerging traceability laws
  • Comply with the U.S. Drug Supply Chain Security Act (DSCSA) Title II Drug Quality Security Act (DQSA)
  • Meet SFDA, ANVISA and ANMAT traceability requirements
  • Comply with GS1, EPCGlobal, EPCIS, and HDMA ASN 856 data exchange standards
Comply with the Food & Drug Administration Modernization Act (FDAMA)
  • Increase market share, profitability and patient safety
  • Provide a foundation for a secure global distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies
  • Trace finished goods across the supply chain for Class II and Class III devices and comply with Federal Drug Agency (FDA) mandates
  • Electronically submit information to the FDA GUDID database
Guarantee the authenticity of origin and demonstrate possession of pharmaceuticals
  • Fight Rx counterfeiting — an estimated 80% of counterfeit drugs identified in the U.S. come from outside the country
  • Ensure compliance with existing and emerging traceability regulations, such as the Drug Supply Chain Security Act (DSCSA)
  • Reduce revenue loss, mitigate brand risk and protect consumers by quickly identifying suspect product in the market, and rapidly initiating targeted recalls if necessary
  • Immediately identify invalid warranty claims
Implement serialization and gain full visibility into your pharma supply chain
  • Trace ingredients and finished goods
  • Manage data exchange between CMOs, wholesalers, distributors and 3PLs
  • Respond to inquiries from authorities, partners and customers about the warranty, recall, destruction status and proof-of-ownership of a product
  • Optimize business processes and effectively manage product recalls involving hundreds of millions of serialized products
Manage controlled substance ordering
  • Replace costly paper-based Form 222 (14-21 days order cycle) with the electronic Form e222 (3-5 days order cycle)
  • Comply with DEA audit requests quickly and efficiently
  • Shorten order cycle times by as much as 18 days
  • Gain real-time visibility and alerting for all orders, acknowledgements and shipping documents
Move to electronic submission of regulated data
  • Submit regulated data to U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japanese Ministry of Health, Labor and Welfare (MHLW)
  • Dramatically reduce the number of paper copies generated for submission and archiving
  • Improve efficiency and enable same-day delivery. Gain visibility into each step of the submissions process
Improve Suspicious Order Monitoring (SOM) with analytics
  • Comply with the U.S. Drug Enforcement Administration (DEA) requirements of Title 21 CFR Part 1301.74 (b)
  • Automatically learn customer profiles and order behaviors, and identify suspicious orders or patterns before they are placed
  • Avoid non-compliance penalties and fines
  • Provide complete end-to-end transaction traceability to support audit and prove compliance based on fact, not perception

Ready to improve supply chain efficiency and ensure compliance?