Cadence Pharmaceuticals is ready to make regulatory submissions through the FDA's Electronic Submissions Gateway (ESG). The biopharma company worked with software provider ISI to implement its eCTDXPress package for compiling, creating, publishing and managing electronic submissions in the electronic common technical document format.
Cadence chose the SaaS package for set-up speed and security, says an announcement. ISI handled deployment and provides IT infrastructure and tech support, including sponsorship of the electronic signature certificate. The SaaS set-up includes a self-contained environment for data protection; daily incremental and weekly full backups are included.
The package provides for various submission formats (eCTD and other electronic formats, as well as paper) and compliance with evolving country-specific guidelines. It covers requirements for both electronic and paper submissions in Australia, Japan, the EU, China, India and Russia, the company says.
ISI separately announced a finding by the French drug authority that it currently rejects half of the non-eCTD electronic submissions it receives because of poor formatting and validation shortcomings. The French regulator says that two-thirds of the electronic submissions it receives arrive in electronic formats other than eCTD.
- see the Cadence announcement
- review the FDA eCTD submissions guidance
- here's the release on French submissions