Go for the Gold with Axway eSubmissions

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

Regulators around the world are driving change in the submissions process, by automating connectivity to suppliers of regulated data. The American Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and the Japanese Ministry of Health, Labour and Welfare (MHLW) have all adopted Axway’s eSubmissions standard to enable industry to submit regulatory documentation.

Designed for pharmaceutical and medical/surgical manufacturers, Contract Research Organisations (CROs) and biotech companies, eSubmissions integrates seamlessly into your existing infrastructure, to quickly and efficiently create cooperative 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,
• Increase income by eliminating delays in submission.