10 Small Submissions
No more than 10 Documents per submission
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.
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 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’s readiness for eCTD 4.0, Please click here to download the archived webinar session.