Come join us for an exclusive in-person seminar on the latest developments in eCTD v4.0, regulatory submissions, and compliance strategies at Tokyo, Japan.  Engage with industry leaders and experts, as we explore the future of global regulatory submissions with an exclusive demonstration of Freyr’s new cutting-edge regulatory submission tool ‘Freya Fusion’, designed to transform eCTD v4.0 publishing and submission management.

Why Attend?

This summit offers an incredible opportunity to:

  • Gain practical insights into eCTD v4.0 adoption in Japan and beyond
  • Learn how Freya Fusion-our cloud-based eCTD v4.0 publishing tool-can enhance your regulatory workflows
  • See real-world case studies and hear from experts about their experiences with eCTD v4.0 submissions in Japan

📌 Let Freyr help with one eCTD v4.0 Japan submission free of cost for you (Conditions Apply)

📅 Event Details

  • Date:
    June 30, 2025
  • Time:
    18:00 to 19:30 (with Q&A)
  • Location:
    Life Sciences Building, Nihonbashi, Tokyo, Japan 📍
  • Format:
    In-person & Interactive
  • Language:
    Japanese
  • Fee:
    Free

Register Now

Who Should Attend?

This seminar is ideal for professionals involved in regulatory affairs, including:

  • Regulatory Affairs Managers
  • Pharmaceutical & Biotech Professionals
  • Compliance Officers
  • Documentation Specialists
  • eCTD Publishing Teams
  • Global Submission Managers

Agenda Highlights

  • What is eCTD 4.0 and its industry significance for times ahead
  • eCTD v4.0 Implementation in Japan – Practical insights and timelines for adoption
  • Introducing “Freya Fusion” – A live demo of Freyr’s eCTD v4.0 publishing platform
    1. Real-time regulatory checks
    2. Global bilingual templates with auto-translation
    3. Integrated traceability and reviewer query management

Register Today to Secure Your Spot!

Seats are limited - don’t miss out on this valuable opportunity to stay ahead in the rapidly changing regulatory environment.
Click below to reserve your seat!

Register Now

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.

 

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 Fusion 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 Fusion 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 Life Sciences Building, Nihonbashi, Tokyo. 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:
Email: sales@freyrsolutions.com
+1 908 483 7958