Axway Life Sciences Comprehensive Regulatory eSubmissions Software

Don’t trust your most important data transmissions to anything less than the gold standard for regulatory submissions: Axway eSubmissions.

Regulators around the world are driving change in the submissions process by automating connectivity to suppliers of regulated data. The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), and the Japanese Ministry of Health, Labor and Welfare (MHLW) have all standardized on Axway eSubmissions for enabling industry to submit regulatory documentation.

Designed for pharmaceutical and medical/surgical manufacturers, Contract Research Organizations (CROs), and biotech companies, eSubmissions integrates seamlessly into your existing infrastructure to quickly and efficiently create collaborative connections that improve the efficiency and lower the costs of transmitting reports to both industry partners and regulatory authorities.

Axway’s platform-independent solution uses adaptive agents and a highly scalable, robust server to securely track and locate each regulatory submission through your communication gateways, translators, and back-end systems — all in real-time.

With the non-intrusive, standards-based eSubmissions software, you can:

  • Send and receive regulatory documents in any format via any industry-standard protocol.
  • Track, monitor, and report on submissions activity for end-to-end process visibility.
  • Ensure the privacy and security of your electronic submissions.
  • Simplify and lower the cost of compliance with data retention and archiving for auditing purposes.
  • Enhance revenue by eliminating submissions latency.
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