If you research, test or develop drugs or medical devices, you need a standardized mechanism for submitting your applications, reports and documentation electronically. Otherwise, you are risking non-compliance penalties, losing valuable time and driving up your costs unnecessarily.
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 to accept regulatory documentation from pharmaceutical and medical/surgical manufacturers, Contract Research Organizations (CROs), and biotech companies.
All you need to do is integrate eSubmissions seamlessly into your existing infrastructure and begin transmitting documents to your partners and regulators.
Axway eSubmissions Key Capabilities
Send and receive regulatory documents in any format via any industry-standard protocols
Track, monitor and report on submissions activity for end-to-end process visibility
Secure and authenticate submissions with encryption and PKI SSL Certificates
Simplify and lower the cost of data retention and archiving required for compliance and auditing
Speed time to revenue by eliminating submissions latency
Eliminate data transcription errors, manual interactions and paper-based processing costs