,The global regulatory landscape is advancing rapidly, and eCTD v4.0 represents the next frontier in submission excellence- offering unparalleled efficiency, interoperability, and compliance readiness. For Japan’s pharmaceutical and life sciences industries, this transition is not just a technical upgrade but a strategic need to align with international standards, streamline approvals, and future-proof regulatory operations.
To help navigate this shift with confidence, Freyr Solutions-a global leader in regulatory technology and consulting-hosted an exclusive in-person eCTD v4.0 workshop in Tokyo, Japan.
This pivotal event brought together industry experts, regulatory professionals, and digital transformation leaders to decode the challenges and opportunities of eCTD v4.0.
The workshop covered:
- The strategic importance of eCTD v4.0 in Japan’s regulatory landscape
- Key differences between eCTD v3.2.2 and v4.0 for a smoother transition
- Best practices for implementation, including structured submissions, regional nuances, and lifecycle management
- Real-world case studies from early adopters and global regulators
- Interactive sessions addressing technical and operational challenges
- Hands-on eCTD v4.0 Submission with freya fusion
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Held on August 28, 2025 in Tokyo, the eCTD v4.0 Workshop 2025 concluded successfully with a strong turnout of regulatory leaders, experts, and professionals. Below are the key highlights.
Workshop Highlights
- Explored eCTD v4.0 concepts, components, and submission structures with a focus on implications for Japan
- Experienced the Freya Fusion submission software in action
- Completed hands-on certification by building a live PMDA eCTD v4.0 sample submission using freya.submit
- Gained insights from Freyr’s CEO and Global Head of Publishing & Submissions, along with other regulatory leaders
Our Audience Profile
- Head of Regulatory Operations
- Senior Director / Director of Regulatory Operations
- Digital Transformation & Compliance Leaders
- Submission Managers
- Regulatory Information Management (RIM) System Manager / Lead
- Regulatory Affairs Professionals
- eCTD Submission and Publishing Processing Team Members
- Regulatory Operations and Systems Group Members
- Regulatory Information Management Team Members
- Regulatory Operations Team Members
Key Takeaways for Participants
- Expert-Led Insights: Learned from Freyr’s global regulatory specialists and industry pioneers
- Actionable Strategies: Received a clear roadmap for successful eCTD v4.0 adoption in Japan
- Regulatory Foresight: Gained understanding of how PMDA and other global agencies are preparing for eCTD v4.0
- Networking Excellence: Connected with peers navigating the same regulatory transition
- Future-Ready Compliance: Acquired strategies to keep organizations ahead in the digital regulatory era
Frequently Asked Questions
This event is designed for professionals in regulatory affairs, including regulatory affairs managers, compliance officers, eCTD publishing teams, pharmaceutical and biotech professionals, documentation specialists, and global submission managers. If you’re involved in the regulatory submission process or looking to streamline your workflows, this summit is for you!
No, the event is free of charge. However, seats are limited, so we encourage you to register early to secure your spot.
The summit will provide you with valuable insights into eCTD v4.0 implementation, real-world case studies, a live demonstration of Freyr’s Freya.Submit platform, and expert discussions on global regulatory submission strategies. You’ll gain a deeper understanding of how to streamline your eCTD publishing workflows and stay compliant with evolving regulations.
Freya.Submit is Freyr’s cloud-based, purpose-built platform designed to simplify eCTD v4.0 publishing. It offers features like real-time regulatory checks, global bilingual templates with auto-translation, and integrated traceability and reviewer query management. This platform is built to help organizations improve their eCTD submission processes and ensure compliance with global regulatory requirements.
The event will be conducted in both Japanese and English. We will have bilingual support to ensure all attendees can engage in discussions and learn from the sessions.
Yes, you can register multiple attendees from your team. Please ensure to provide all necessary details for each participant when registering.
We understand that schedules can change. If you're unable to attend, please notify us as soon as possible so we can offer your seat to someone on the waiting list. Unfortunately, we are unable to provide virtual access to the event at this time.
The event will take place at the Edogrand, 22F, 2 Chome-2-1 Kyobashi, Chuo City, Tokyo 104-0031 (Get Directions). Details on how to reach the venue and parking information will be sent to you in a confirmation email after registration.
If you have any additional questions, please feel free to reach out to us at:
Yooya.Matsumura@FreyrSolutions.com | +81 803 571 4198
Yooya.Matsumura@FreyrSolutions.com | +81 803 571 4198
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About Freyr
Freyr is a trusted global leader in regulatory services, specializing in pharmaceutical, biotech, and medical device industries. With a deep understanding of the evolving regulatory landscape, we help organizations stay compliant, agile and future-ready. At our core, we are driven by innovation-delivering solutions that combine cutting-edge technology with years of hands-on industry experience.
Whether it’s through our consulting services, platform tools, or compliance strategies, Freyr is here to empower your regulatory processes with the latest technology and expertise.
Recognized as a Leader in the PEAK Matrix® for Life Sciences Regulatory Services, Freyr continues to set the standard for regulatory excellence-delivering future-focused solutions that support faster approvals and sustainable compliance in a global market.