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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

Freyr SUBMIT PRO eCTD Subscription Plans

  • SUBMIT PRO GEO

    A starter pack to quickly make your submission.

    Per user per year
    $3750

    Includes:

    • 1 Health Authorities (HA) Read More
    • Unlimited Submissions per HA
    • Regulatory Intelligence Access Read More
    • eCTD Viewer + Validator
    • eCTD Import Utility
    • Global Support Read More
    • $1450 for every additional HA Read More

    Subscribe

  • SUBMIT PRO LEASE

    You can opt for SUBMIT PRO GEO for less than a year

    Per user

    3 Months $1750

    6 Months $2750

    Includes:

    • Publishing Handyman Read More
    • 2 Health Authorities (HA)
    • Unlimited Submissions per HA
    • Regulatory Intelligence Access
    • eCTD Viewer + Validator
    • eCTD Import Utility
    • Global Support Read More
  • SUBMIT PRO ASSIST

    An end to end software and publishing services bundle

    Per Year
    $24,000

    Includes:

    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.

    Subscribe

  • 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

    Contact us

Note: All prices mentioned are in USD

know more
about Freyr SUBMIT PRO

www.ectdtool.com

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