https://www.freyrsolutions.com/
Freyr Solutions – Global Regulatory Services for Life Sciences

Freyr Solutions is the world\'s largest provider of end-to-end regulatory services for life sciences, including pharmaceuticals, medical devices, consumer healthcare, cosmetics, food supplements, and chemicals. Our services encompass regulatory consulting, operations, technology, and compliance across 120+ countries.

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....rvices-and-solutions

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....atory-transformation

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....nes-trends-readiness