Global eCTD 4.0 Electronic Submissions Simplified!

Stay Ahead of the Curve with Freyr - The First to Launch eCTD 4.0 submission services and regulatory software for PMDA & US FDA

Freyr is one of the first regulatory service providers fully equipped for eCTD 4.0 electronic publishing and submissions. With proven delivery for Japan PMDA and pilot readiness for US FDA, we offer unmatched expertise, proprietary tools, and full-spectrum support for a seamless global transition.

eCTD 4.0 US FDA and eCTD 4.0 Japan PDMA are currently accepting eCTD 4.0 submissions voluntarily; however, Japan will mandate eCTD 4.0 from April 2026. Other countries are still in the process of implementation.

Be eCTD 4.0 Submission-Ready Before the Deadline!

Why Top Pharma Companies Trust Freyr for eCTD 4.0

Early Mover Advantage

First in the industry to deliver LIVE eCTD 4.0 submissions for PMDA
Ready for US FDA eCTD 4.0 pilots (Q3 2025) and EU readiness by end of 2025

Deep Regulatory Collaboration

Partnering with PMDA, US FDA & EMA on sample and pilot submissions
Hosting the Japan-wide eCTD 4.0 Industry Summit (August 2025)

Proven Performance

200,000+ global eCTD submissions delivered
99% “Right First Time” record
Zero Refusal-to-Receive (RTR) outcomes

Take the first step toward seamless global compliance

What We Offer

eCTD 4.0 Advisory & Training

Country-specific guidance for Japan, US, EU & more
In-house team trainings, SOPs, and region-specific templates

Full-Service Submission Support

End-to-end eCTD 4.0 lifecycle management: IND, NDA, ANDA, MAA, BLA, LCM, etc.
Publishing, validation, dispatch & agency follow-up

freya. Submit: Robust Software Tool for Global eCTD submissions

Use Freyr’s industry-proven eCTD publishing and electronic submission software, freya. Submit.
Automation solutions to reduce manual QC efforts

Dedicated COEs for PMDA & FDA

25+ Japan-focused regulatory experts
Seamless coordination across global hubs: US, Japan, EU, India

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Global eCTD 4.0 Implementation and Submissions

Freyr is partnering with major pharmaceutical companies in Japan to support eCTD 4.0 submissions to the PMDA, including training, live submissions, and proof-of-concept (POC) activities-successfully delivering multiple submissions to date.
As a leading software partner, Freyr is working closely with the PMDA to provide technical consultation, ensuring full compliance with eCTD 4.0 Japan-specific requirements.
Freyr is also supporting multiple clients with pilot submission for the eCTD 4.0 US FDA and is currently collaborating with EU Health Authorities on samples of eCTD 4.0 submission.
Through strategic partnerships and regulatory expertise, Freyr is helping global pharmaceutical companies smoothly transition to eCTD 4.0-starting with Japan and expanding into the US and EU markets.

Global eCTD 4.0 transition across:

Health Canada

Australia TGA

Brazil ANVISA

South Korea MFDS

eCTD 4.0 benefits:

Efficiency: eCTD 4.0 streamlines the regulatory submission process, saving sponsors time and money.
Accuracy: Controlled vocabularies in eCTD 4.0 ensure that regulatory submissions are consistent and accurate.
Communication: eCTD 4.0 improves communication between sponsors and regulatory authorities by providing a more collaborative review process.

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Don't Wait for Mandates. Lead the Change.

Most health authorities will mandate eCTD 4.0 by 2026–2027. Be ready before it’s too late.
With 20+ global hubs, 400+ publishing experts, and partnerships with 200+ pharma companies, Freyr is the preferred regulatory partner for leading life sciences brands worldwide.