Overview

Smarter the electronic Common Technical Document (eCTD) publishing software, smoother will be the eCTD submissions process. But to ensure the smoother submissions, life sciences organizations must consider the wide variety of documentation they need to manage.  The entire documentation Life cycle covers a complete clinical and pre-clinical research data accumulated over the years. In addition, region-specific submission requirements (across the USA, the European Union, Canada, Gulf Cooperation Council (GCC), Saudi Arabia, Oman, South Africa, Switzerland, Australia, New Zealand, Bosnia & Herzegovina, and Thailand) vary depending on the respective Health authority (HA) regulations and, thus the submission templates and formats. Likewise, as organizations move towards fulfilling their submission obligations, either Drug Master File (DMF) or baseline submissions, under strict compliance timelines, they face increasing complexities to efficiently manage different eCTD templates / formats across the entire submission life cycle.

Some of the major challenges faced by organizations include:

  • Need for a robust Regulatory publishing software to streamline and effectively manage the entire Life cycle, and to root out all errors during the submissions compilation and validation
  • Ineffective submission solutions due to partial integration with commonly available Document Management System (DMS)
  • Unending performance issues due to complex architecture & unnecessary features of the eCTD software
  • Unfriendly and rigid eCTD submission software structure with limited customizable product features
  • Unavailability of end-to-end eCTD Software vendors

In such scenarios, life sciences organizations look for a robust and effective submission publishing software / eCTD Regulatory software to gain approvals from HAs on fast-track basis for marketing new drugs, biologics, and devices. Freyr as an end-to-end eCTD Regulatory software provider assists organizations with Freyr SUBMIT to effectively handle all the Regulatory submissions requirements, that is, handling end-to-end document life cycle and region-specific eCTD templates / formats. 

 

Freyr SUBMIT Expertise

End-to-end DMF and baseline submissions workflow with detailed checks during compilation, validation, and publishing functions
Robust audit trail & reporting mechanism
A web-based eCTD software with advanced admin functions with capabilities to monitor the lowest level user activity & highly customizable access management
Effective validation of each and every user activity via electronic signatures
Flexible eCTD publishing software for end-to-end Regulatory submission publishing services
 

Freyr SUBMIT Features

  • A lightweight and faster application built on a robust architecture with a simple, user-friendly interface
  • A ready-to-use, flexible and cost-effective eCTD Regulatory software offered either as a cloud hosted or on-premise deployable model
  • Easily processes USA, Europe, GCC, Australia, and Thailand eCTD submissions with automated system-defined eCTD templates / formats 
  • Our web-based eCTD software supports emerging market submission requirements
  • Enables automated template library updates (for all formats/templates) with systematic and customized notifications
  • Advanced features to efficiently manage the entire eCTD Life cycle
  • Completely customizable eCTD Regulatory software with advanced reporting, audit trail, and admin features
  • Our cloud-based eCTD solution enables seamless integration with prominent DMS

 

To Know More about Freyr SUBMIT and to take a feature-specific comprehensive product tour.

Get a Quote / Request a Demo
 

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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