accelerate and streamline
Regulatory submissions from planning to tracking
Freyr SUBMIT PRO electronic Common Technical Document (eCTD) publishing software eases the eCTD submission process. Designed from the ground up, and with over a decade of experience, it effectively creates, validates, tracks, publishes and manages the entire document life cycle, including complete clinical and pre-clinical research data.
Regulatory teams also benefit from considerable versatility with region-specific submission formats under strict eCTD guidelines and compliance timelines. It means Freyr SUBMIT PRO helps effectively cut the time-consuming management and conversion of source data into different region-specific eCTD templates/submission formats.
collaborative submission preparation & review
FDA 21 CFR part 11 and EU GMP annex 11 compliant
eCTD viewer capabilities to review the submission lifecycle of all regions
supports Integration with leading EDMS
need submission support
inbuilt PDF bookmark and link manager
inbuilt validator to check submission compliance
eCTD templates for all regions
integration with leading rDMS
inbuilt eCTD viewer
inbuilt PDF manager