Comprehensive Support for Japan eCTD v4.0 Submissions
Last updated: September 2025
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is modernizing its submission framework by transitioning from eCTD v3.2.2 to version 4.0. Following pilot initiatives that began in 2022, full compliance for new drug applications (NDAs) is set to be mandatory by 2026. Early readiness is vital to prevent delays, errors, and rejection.
Freyr Solutions is your strategic partner for this regulatory evolution. We guide pharmaceutical and biologics companies through every stage of dossier preparation, validation, and submission while ensuring adherence to Japan’s specific requirements. Our technology-driven approach, backed by extensive experience, simplifies the regulatory journey from submission to post-submission lifecycle management.
Learn how our smart regulatory solutions streamline submission processes and enhance compliance.
Why Choose Freyr for Japan eCTD v4.0 Submissions?
PMDA-Compliant Expertise
Our team is specialized in Japan’s unique eCTD v4.0 requirements, ensuring every document is compliant and submission-ready.
End-to-End Support
From converting dossiers to managing lifecycle updates, we provide seamless support at every step of the submission process.
AI-Driven Regulatory Technology
With tools like freya submit, powered by AI algorithms, we ensure efficiency and accuracy in every submission.
Local Insight
Benefit from our Japan-based experts who understand regional nuances and can guide you through complex regulatory requirements.
Faster Approvals
Accelerate your submissions with proven workflows and expert teams that ensure timely compliance with PMDA protocols.
Key Features of Japan’s eCTD v4.0
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Mandatory Compliance by 2026
All NDAs in Japan must meet eCTD v4.0 submission standards. -
Strict Validation Protocols
Non-compliant submissions risk rejection due to PMDA’s stringent formatting and metadata rules. -
Lifecycle Management Support
We assist in managing updates, renewals, amendments, and version control for seamless regulatory continuity.
Technical Evolution: From PDF to XML
Our Japan eCTD v4.0 Submission Services
Dossier Preparation & Publishing
We convert files into submission-ready formats incorporating regional and ICH guidelines:
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Document-level enhancements with hyperlinks and optimized formatting
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Submission-level publishing including XML backbone creation and lifecycle tracking
Regulatory Submission & Validation
We conduct thorough PMDA validation checks and manage secure submissions via PMDA’s gateway.
Post-Submission Support
Our team handles queries, deficiency notices, amendments, renewals, and version control to ensure uninterrupted compliance.
Consulting & Training
We assess readiness with gap analysis, train in-house teams, and design regulatory strategies for smooth approvals.
Partner with Freyr for Regulatory Excellence
With technology-driven tools and expert guidance, Freyr makes navigating Japan’s regulatory landscape simpler and more efficient. Explore how our solutions ensure submission readiness and compliance by visiting our Japan eCTD v4.0 services page.
Ensure regulatory success with Freyr—where expertise meets innovation.
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