,Master the Transition to eCTD 4.0 with an Expert Partner
The global standard for regulatory submissions is evolving. eCTD 4.0 introduces significant improvements over previous versions, designed to enhance efficiency, accuracy, and communication between life sciences companies and health authorities. Key upgrades like forward compatibility and controlled vocabularies streamline the submission process, ensuring your applications are consistent and compliant.
With regulatory bodies like Japan's PMDA mandating eCTD 4.0 by 2026 and the US FDA, EMA, and others following suit, the time to prepare is now.
Be eCTD 4.0 Submission-Ready Before the Deadline!
Why Partner with Freyr for Your eCTD 4.0 Transition?
Freyr is at the forefront of the eCTD 4.0 transition, offering proven expertise and advanced software solutions to ensure your organization is ready before the deadlines.
Early Mover & Proven Expert
We are among the first to deliver live eCTD 4.0 submissions for Japan's PMDA and are actively supporting clients with pilot programs for the US FDA.
Comprehensive Service Partner
From strategic advisory and training to full-service submission management and our proprietary Freya.Submit software, we provide end-to-end support.
Global & Regional Expertise
Our teams are working closely with the PMDA, US FDA, and EU Health Authorities to ensure our solutions meet specific regional requirements, helping you navigate the transition in Japan, the US, and the EU.
Our advanced software, Freya.Submit, is being updated to fully support eCTD 4.0, providing a seamless, tech-enabled solution for your regulatory submissions.
Unlock the Benefits of eCTD 4.0
Adopting eCTD 4.0 offers a competitive advantage by improving your entire regulatory workflow:
Greater Efficiency: Streamline your submission process to save valuable time and resources.
Enhanced Accuracy: Utilize controlled vocabularies to ensure information is consistent and error-free.
Improved Communication: Foster a more collaborative and transparent review process with health authorities.
Assured Compliance: Leverage a robust validation process to meet all regulatory requirements confidently.