Launch Confidently
into Japan with Freyr
Regulatory Experts
From PMDA compliance to GxP readiness - streamline your entry
into the Japanese pharma market.
Need Help with Japan Market Entry?
Celebrating Customers Success
Sr. Director, Head of Regulatory OperationsIreland-based, Global Specialty Pharmaceutical Company
Medicinal Products
Publishing
UK
I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.
Thank you Freyr team for a job well done!
Ed VenkatGlobal CMC Technical Lead
Medicinal Products
Publishing and Submission
UK
We would like to appreciate Freyr’s quick TAT to push through an urgent submission required by the FDA. Their efficiency, diligence, excellence, sense of urgency, and priority are deeply flexibility.
Please keep up the great work as we have many milestones to achieve over the next year.
Lynne McGrathRegulatory Consultant
Medicinal Products
Regulatory Affairs
USA
Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.
Thank you for always being available and responding quickly and comprehensively to all my requests.
What a great team you have, Freyr.
Michael Bellero Sr. Director, Head of Regulatory Operations
Medicinal Products
Publishing and Submission
UK
I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.
Thank you Freyr team for a job well done!
Vice President R&DCanada-based, Leading OTC Products Company
Medicinal Products
Regulatory Affairs
Canada
Thanks for sending the invoice. The activities and amounts generally mesh with our expectations. The provided resource is doing a great job managing our projects and keeping us informed of the status. We are very happy with her diligence, professionalism, and high level of service. For tracking these types of hourly activities in our internal records, it would be helpful if you could provide a summary of the hours by month or by country if that is possible.
System OwnerUK-based, Multinational Pharmaceutical and Biotechnology Company
Medicinal Products
Regulatory Affairs
UK
Thank You, Freyr team, for a Fantastic 2019! The OTC DOCS TD user community feels better supported despite the technical challenges and system constraints. Thank you for being the voice to represent their ways of working and helping us design a more user-friendly and effective system going forward.
Director RAUS-based, Leading Generic Pharmaceutical Company
Medicinal Products
Regulatory Affairs
USA
I just wanted to say how pleased we are with your resource's work. He has quickly come up to speed and is doing a great job.
Thank you for listening to our needs and finding such a great match.
Quality Control and Regulatory ManagerUS-based, Nutraceutical Products Manufacturing Company
Medicinal Products
Regulatory Affairs
USA
This project, eCTD DMF conversion, was against a very tight schedule and required dedicated resources. Freyr provided the dedicated resources needed to meet our immediate Regulatory filing requirements. Freyr was always on schedule/or exceeded the dates outlined in the project plan. All changes were handled within 24 hours, and notifications of changes were promptly provided. This project is not yet complete but has been very successful until this point.
Global CMC Technical LeadChina-based, Leading Innovator Pharmaceutical Company
Medicinal Products
Medical Writing
UK
We are extremely happy to inform you that the BLA was successfully submitted to the FDA. We convey our sincere gratitude to the Freyr team, who worked diligently, tirelessly, and very closely with our Bridgewater and Beijing teams over the past several months to accomplish this monumental feat on time. Freyr’s team went beyond the call of duty to make this BLA submission come true. We truly appreciate Freyr’s flexibility and eagerness to work with us to accomplish aggressive goals. Look forward to your perennial support and our continued relationship and beyond.
Why Regulatory Compliance in Japan Requires Specialized Expertise
Japan’s Regulatory framework is unique (PMDA, MHLW, FMA, GQP, GVP, GCP distinctions)
Global pharma often faces setbacks without local alignment
Freyr brings in bilingual experts and Japan-localized dossier guidance
Here’s how Freyr can help
PMDA submission planning & lifecycle management
Japan CTD (J-CTD) and J-NDA support
eCTD conversion aligned with Japanese vocabulary
FMA (Foreign Manufacturer Accreditation) readiness
Local representative coordination and QMS advisory
99%
First-Time Right Submission Rate: Because precision matters, we deliver accuracy from the start.
99.99%
On-time delivery, every time: Stay ahead of deadlines with seamless execution and zero surprises.
0%
No Refuse-to-File errors: Complete, compliant, and submission-ready – the first time.
100%
RI-Powered Precision: 100% integration of Regulatory Intelligence in every submission process.
15+
Trusted by Pharma Leaders: 15+ leading Pharmaceutical & Biologic companies rely on our expertise.
580+ and 55+
580+ global and 55+ local clients choose us because we don’t just meet expectations, we understand them.
Freyr in Media
Why Choose Freyr

Unmatched Global Regulatory Force
Leverage the power of 150+ Regulatory experts delivering market-specific insights and submission excellence across regions, with a sharp focus on Japan.
Over 8 Years of Proven Success in Japan
With 8+ years of hands-on experience navigating Japan’s complex Regulatory landscape, Freyr has established a solid track record in PMDA submissions, J-CTDs, and J-NDAs.
Fluent in Compliance-And in Japanese
Our bilingual experts ensure precise documentation and communication with PMDA, removing language barriers and accelerating approval timelines.
Global Strategy, Local Precision
Freyr combines international Regulatory know-how with deep local understanding to deliver fully aligned, audit-ready submissions from day one.
Why Life Sciences Companies Choose Freyr for Regulatory Support
Capability | Freyr Solutions | Other Providers | Advantage |
---|---|---|---|
J CTD & J NDA Support | Precision to PMDA format and lifecycle | ||
eCTD Conversion with Japanese Vocabulary | Ensures PMDA-acceptable dossier structure | ||
PMDA-Compliant Validation Tools | Higher submission accuracy and success rate | ||
FMA (Foreign Manufacturer Accreditation) | Comprehensive compliance readiness | ||
Local Representative & QMS Advisory | Fully integrated support, including audits | ||
Label & Package Insert Compliance | Holistic submission readiness | ||
Lifecycle Query & Resubmission Management | Smoother post-submission flow |
Success Stories
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Freyr Provided Comprehensive Regulatory Support Accelerating Global Submissions and Ensuring Compliance for a Japanese Pharmaceutical and Biotechnology Company Across Multiple Markets
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Freyr Streamlined and Standardized Submission Processes for a Japanese Drug Manufacturer's Successful Market Entry into the US Market
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Freyr Provided Comprehensive Regulatory Support for Managing Partial Change Applications, Renewals, and Variations for a Global Healthcare Company in China and Japan
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Freyr Provided Strategic Regulatory Partnership Achieving 100% On-Time Submissions and 50% Cost Savings with a Scalable Hybrid Staffing Model for a Japanese Midsize Global Pharma and Biotech Company