10 Small Submissions
No more than 10 Documents per submission
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
Freyr SUBMIT PRO eCTD Subscription Plans
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SUBMIT PRO GEO
A starter pack to quickly make your submission.
Per user per year
$3750Includes:
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SUBMIT PRO LEASE
You can opt for SUBMIT PRO GEO for less than a year
Per user
3 Months $1750
6 Months $2750
Includes:
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SUBMIT PRO ASSIST
An end to end software and publishing services bundle
Per Year
$24,000Includes:
SUBMIT PRO GEO + Publishing Services
- SUBMIT PRO Geo for 3 named Users
- Publishing Services
SUBMIT PRO ASSIST is also available at a less than a year cost. Contact Us to know more.
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SUBMIT PRO ENTERPRISE
SUBMIT PRO GEO or ASSIST at a scalable level
Includes:
- All Regions
- DMS Integrations available Read More
- Import Utility Available
- Cost effective solutions available
Note: All prices mentioned are in USD
