Axway Global Serialization, Compliance, Track and Trace, Pharmaceutical and Biotech Solutions
Established in 2001, Axway provides software solutions for healthcare and life sciences companies worldwide.
Companies rely on Axway 5 suite that include application programming interface (API) management, business-to-business (B2B) integration, email security and managed file transfer (MFT) offered on premise and in the Cloud, to manage business-critical interactions through the exchange of data flowing across the enterprise, among B2B communities, cloud, social, mobile and the Internet of Things (IoT).
The top 25 pharmaceutical companies, top three pharmaceutical distributors, nine of the top ten pharmacy retailers are all Axway customers.
Core mandates for life sciences companies and research organizations around the world include protecting sensitive PII, PHI, and intellectual property against leakage and loss, ensuring regulatory compliance by securing information at rest in transit, and keeping the supply chain safe and efficient.
Complete end-to-end data flow governance and compliance
Axway offers comprehensive solutions that address business-to-business (B2B) data exchange processes, security policies, governance and compliance requirements for the life sciences industry. Axway’s integrated suite helps many of the leading life sciences companies comply with DEA regulations around controlled substances, submit clinical trials and adverse events to regulatory agencies for speedy and accurate processing of new drug applications, and help companies meet requirements outlined in the Drug Quality and Security Act (DQSA).
Global serialization and compliance: track and trace
Axway Global Serialization and Compliance guarantees authenticity of origin and demonstrates possession as pharmaceutical drugs move through the supply chain, delivering a clear trail of ownership at each step of the process.
Axway Global Serialization and Compliance provides end-to-end transparency, supply chain logistics management and product authentication services across even the most complex supply chains, and has delivered a proven foundation for meeting emerging global regulatory requirements for serialization including China, Korea, Turkey, Europe, and DQSA in the US.
Internet security and managed file transfer (MFT)
The company provides secure, auditable, and easy-to-manage real time and batch data exchange and identity management security solutions. Axway allows medical device manufacturers, pharmaceutical, and biotech companies (including research labs) to leverage the existing systems they already have in place to securely exchange sensitive information with their partner ecosystem.
Axway Control Substance Ordering System (CSOS) helps significantly reduce expenses, increase security, and ensure compliance with US DEA regulations for the order and management of controlled substances.
Axway eSubmissions is the gold standard for regulated submissions, adopted by regulators in Japan, Europe and the US.
Products and Services
In today's business climate, time-to-market is vital for geting an edge over competition.
Axway Track & Trace
Combat counterfeit drugs, enhance patient safety and protect brand integrity with Axway Track & Trace and GS1 EPCIS.
Controlled Substance Ordering System (CSOS)
Axway CSOS makes it easy for buyers and suppliers of regulated pharmaceuticals to reduce operational expenses and increase security while ensuring real-time compliance with US Drug Enforcement Administration (DEA) regulations.
Axway Track & Trace (GS1 EPCglobal-Certified)
Axway Track & Trace manages serialized and non-serialized product events to allow internal and external trusted parties to access product identification, location, pedigree and event data at any point in the delivery supply chain.
GlaxoSmithKline’s (GSK) Pharmaceutical Tablet Manufacturing Factory, Karnataka
Rosalind Franklin Biotechnology Center, Delft
Alnylam’s Manufacturing Facility, Norton, Massachusetts
The life sciences industry involves many participants from various organisations, requiring each to have visibility into controlled substances as they move through the supply chain process, while still maintaining security and compliance regulations.Read more