January 4, 2023
Regulatory submissions and publishing tasks have traditionally been laborious involving hours of manual efforts for formatting documents, generating agency-compliant PDFs, doing quality checks, assembling documents for submissions, etc. With the demanding timelines, life science companies always rush for timely submissions. Across the globe, Regulatory bodies are gearing up to adopt recent developments like eCTD v4.0 for dossier submissions, amendments, and other reports. eCTD v4.0 is an incremental change likely to impact the future of Regulatory submissions, with every country gearing up to accept and implement it.
Considering all the challenges around Regulatory submissions, the need of the hour is a technologically advanced solution to boost the drug submission and review process. Since organizations are already considering automation to become an integral part of the Regulatory submission process, it is crucial to consider how it can enhance productivity while transitioning to eCTD 4.0.
How Automation Aids in the Transition to eCTD 4.0?
- At the cusp of adopting the latest version of the eCTD, deploying automation into the Regulatory submission process can bring in double benefits for life sciences companies that include ensuring compliance to eCTD v4.0 in quicker time on one (01) hand and enhancing data consistency & submission process streamlining on the other hand.
- Once the data has been finalized for use in one (01) Regulatory filing, automation makes it possible for data to populate in other submissions or updates. It takes advantage of the new feature in the eCTD v4.0, which now allows many-to-one and many-to-many data replacements, thereby enabling the reuse of the data in a simplified way.
- Automated notifications remove the need to deliver messages or make phone calls when the activity is required. It enables faster, clear communication leading to controlled vocabularies, an essential component of eCTD v4.0.
- Automation in document submission will help to further ease the process of content upgradation that is already submitted. It will enhance the life cycle control of the submitted documents.
- Automation in context groups can fasten the process of organizing multiple files meant to be used for Regulatory submissions.
Amidst the transition to eCTD v4.0, it is crucial for life sciences organizations to partner with vendors who are ready for the new standard and understand how to automate and streamline the Regulatory publishing process. Companies need to buckle up for adopting the latest technologies enabled by automation to gain prominent benefits and a competitive advantage in the market. eCTD v4.0 is a major change that has come after a long time. Organizations need to start their proof of concept to test the waters as it will soon be accepted in many countries worldwide, depending upon each country’s timelines.
We at Freyr Digital are at the forefront of driving innovation through technology and are geared to support our customers by making our Regulatory submission and publishing software - Freyr SUBMIT PRO eCTD v4.0 ready.
To know more about Freyr Digital's readiness for eCTD 4.0, Please click here to download the archived webinar session.
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