https://www.freyrsolutions.com/
Freyr Solutions is a global regulatory and compliance partner catering to life sciences firms. They specialize in regulatory intelligence, market access, product registrations, and post-approval services across diverse geographies to ensure medical, pharmaceutical, cosmetic, and food products meet regulatory standards.

Freyr Japan • End-to-End PMDA eCTD v4.0 Submission & Compliance Services

Description:
Freyr Japan offers full-lifecycle support for PMDA-compliant eCTD v4.0 submissions — from dossier conversion, XML publishing, and validation to post-submission queries, training, and readiness consulting. Be ready for mandatory compliance by April 2026.
https://japan.freyrsolutions.c....om/freyr-japan-pmda-

eCTD v4.0 in Japan: Navigating the 2026 Regulatory Transformation

Description:
Japan’s regulatory landscape is shifting: with PMDA mandating eCTD v4.0 starting April 2026, pharmaceutical companies must adapt now. This article outlines changes in submission format, compliance timelines, technical requirements, and readiness strategies to ensure a smooth transition.
https://japan.freyrsolutions.c....om/blogs/ectd-v4-0-i

Japan & the Global eCTD v4.0 Wave: Key Timelines, Trends & Readiness for Pharma
Explore how Japan and the world are preparing for eCTD v4.0. From PMDA’s April 2026 implementation to EU and US roll-outs, learn the trends, regional nuances, and strategies pharma companies need to stay ahead.
https://japan.freyrsolutions.c....om/blogs/japan-and-t

How eCTD v4.0 Is Transforming Pharma Regulatory Submissions in 2025

Discover how the new eCTD v4.0 standard will reshape regulatory submissions for pharmaceutical companies in 2025. From Japan’s PMDA mandates to global implementation timelines, metadata changes, and streamlined document reuse — learn what you need to know to stay compliant and ahead of the curve.
https://japan.freyrsolutions.c....om/blogs/how-ectd-v4