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submit pro

Advanced eCTD software for the entire document life cycle – from submission creation and publishing through tracking and managing your workflow.


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.

functional highlights


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


NeeS submission support


inbuilt PDF bookmark and link manager

key features

inbuilt validator to check submission compliance

eCTD templates for all regions

integration with leading rDMS

inbuilt eCTD viewer

inbuilt PDF manager

module cloning

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