Overview

Smarter the electronic Common Technical Document (eCTD) publishing software, smoother will be the eCTD submissions process. But to ensure smoother submissions, life sciences organizations must consider the wide variety of documentation they need to manage.  The entire documentation lifecycle covers a complete clinical and pre-clinical research data accumulated over the years. In addition, region-specific submission requirements vary depending on the respective Health Authority (HA) regulations and, thus the submission templates and formats.

Some of the prominent HAs are: Food and Drug Administration (FDA) for USA, European Medicinal Agency (EMA), Health Canada, Saudi Food and Drug Administration (SFDA), Ministry of Health (MOH) – Oman, Medicines Control Council (MCCZA) for South Africa, Swiss Medic, Taiwan Food and Drug Administration (MOPH) for Thailand, Australian Therapeutic Goods Administration (TGA), Chinese Food and Drug Administration (CFDA) and so on.

Likewise, as life sciences organizations such as pharmaceutical, biotechnology, and medical devices companies move towards fulfilling their submission obligations, under strict eCTD guidelines and compliance timelines, they face increasing complexities to efficiently manage different eCTD templates / formats across the entire submission lifecycle while managing eCTD conversion of existing data. Some of the major application types are:

  • 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)

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 tools and software
  • Unfriendly and rigid eCTD modules and submission software structure with limited customizable product features
  • Unavailability of end-to-end cloud-hosted 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 baseline, DMF, IND, NDA, ANDA, MAA, NDS, ASMF, BLA, and IMPD workflow with detailed checks during compilation, validation, and publishing functions
  • Robust audit-trail & reporting mechanism
  • A web-based and cloud-hosted eCTD software with advanced admin functions
  • Capable to monitor the lowest level user activity & highly customizable access management
  • Effective validation of each user activity via electronic signatures
  • Flexible eCTD publishing software for end-to-end Regulatory submission publishing services
  • Exclusive support for preparation and submission of baseline, DMF, IND, NDA, ANDA, MAA, NDS, ASMF, BLA, and IMPD dossiers
  • Aids in preparation and submission of BLAs/MAAs for recombinant therapeutic proteins, vaccines and other biological products while keeping with the regional specifications
 

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 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 tool supports emerging market submission requirements
  • Our cloud-hosted eCTD software enables seamless integration with prominent DMS
  • Enables automated template library updates (for all formats/templates) with systematic and customized notifications
  • Advanced features to efficiently manage the entire eCTD Lifecycle
  • Completely customizable eCTD Regulatory software with advanced reporting, audit trail, and admin features

 

To Know More about Freyr SUBMIT, an eCTD Software and its price, 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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