Overview

Smarter the electronic Common Technical Document (eCTD) publishing software, smoother will be the eCTD submission process. But to ensure smoother submissions, life sciences organizations must consider wide variety of documentation they need to manage.  Handling the entire documentation lifecycle inclusive of complete clinical/pre-clinical research data might be challenging for applicants. In addition, under strict eCTD guidelines and compliance timelines, they may face increasing complexities to efficiently manage or convert the existing data into different region-specific eCTD templates / submission formats. Some of the major application types they may have to submit include:

  • Investigational New Drugs (INDs)
  • New Drug Applications (NDAs)
  • Abbreviated New Drug Applications (ANDAs)
  • Marketing Authorization Applications (MAA)
  • New Drug Submission (NDS)
  • Abbreviated New Drug Submission (ANDS)
  • Drug Master File (DMF)
  • Active Substance Master File (ASMF)
  • Investigational Medicinal Product Dossier (IMPD)
  • Biological License Applications (BLAs)

In such scenarios, apart from the accuracy of the data that is required to submit, life sciences organizations should also look for a robust and effective eCTD tool / publishing & submission software for faster, compliant and seamless submissions. Freyr, providing an advanced eCTD publishing software - Freyr SUBMIT PRO - effectively handles clients end-to-end global publishing and submission requirements, from creating, validating and publishing the data as per region-specific eCTD templates/formats to submitting them for quick reviews and approvals.      

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About Freyr SUBMIT PRO

www.ectdtool.com
 

Freyr SUBMIT PRO Expertise

  • Collaborative submissions, preparation and review
  • Health Authority query management
  • Flexibility to integrate with leading eDMS
  • Effective and automated validation of each user activity via electronic signatures
  • Meticulous reporting
  • End-to-end submission tracking
  • Automated global eCTD templates
  • 21 CFR part 11 compliant
 

Freyr SUBMIT PRO Features

  • Inbuilt Validator
  • Inbuilt eCTD Viewer
  • Inbuilt PDF Manager
  • Import Utility
  • Module Cloning
  • Cross Reference Functionality
  • Robust audit trail & reporting mechanism
  • A web-based eCTD software
  • Lightweight, Flexible and Robust
  • Advanced notification system
 
  • Seamless integration with Documentum, which allows document drag and drop whilst keeping track of all your versions alongside maintaining existing review cycles
    • Reduces re-work in authoring/publishing
    • Effectively collaborates global teams to increase productivity
    • Eliminates potential errors caused my manual submissions
    • Supports virtual documents
    • Completely tracks submissions and saves efforts

Know More
About Freyr SUBMIT PRO

www.ectdtool.com
 

Freyr Service

Freyr assists Life sciences organizations streamline entire Health Authority (HA) Submission Management Process, right from dossier development, submission planning, tracking, publishing and final submission to HA including Delivery Confirmation/Acknowledgement, to ensure error free, timely and quality submissions throughout the Submission Lifecycle. Freyr supports electronic, paper, eCTD, NeeS submission formats.

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