Throwback 2018 – the regulatory summary in a nutshell

On-time Regulatory submission is the key to achieve quick time-to-market. But, with a lack of planning, the industry could face a lot of complications which may result in rejected submissions, delayed market-entry, increased costs due to extended timelines. Hence, it is necessary to develop a concrete submission plan and identify where technology can help improve Regulatory submissions. 

Health Authorities are now going the eCTD way! Many countries, such as the US, Europe, Canada, South Africa, Australia, Thailand and Japan, have already chosen eCTD as a standard format for submissions because of the various advantages like:

  • eCTD allows to automatically upload sequences with the help of XML backbone
  • There is no need to store a large number of paper documents
  • Reviewers can easily refer to the information with the help of hyperlinks
  • Changes or updates made to the dossiers can be easily identified
  • End-to-end product lifecycle tracking
  • Simultaneous accessibility of documents is possible

Though the format seems to be advantageous, eCTD Regulatory submissions are not simple. The process can be time-consuming and highly prone to errors, if not executed in the right manner. By using an eCTD tool, it is easy to significantly increase the quality and reduce the preparation time. Here are the ideal features to consider while choosing Regulatory publishing and submissions software:

  • The tool must comprise of an inbuilt validator, eCTD viewer and PDF manager for effective automated validation, preparation and review of dossiers
  • It should be equipped for Health Authority query management
  • It must be lightweight, robust and flexible to integrate with leading eDMS
  • It should offer a meticulous reporting mechanism
  • It must enable end-to-end submission tracking
  • The tool must possess automated global eCTD templates
  • A web-based eCTD software
  • It should contain an advanced notification system

To conclude, as global Health Authorities are making eCTD submissions mandatory and trying to harmonize the global Regulatory requirements for streamlined submissions, companies must act wise and deploy a software solution that indeed shall suit all the global submission requirements. Evaluate Freyr SUBMIT PRO for all your publishing and submission requirements. Request a demo.

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