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

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.

Why Choose Freyr

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
Comprehensive module-by-module management, including Japanese context and lifecycle tracking.
General eCTD only; lacking Japan-tailored J CTD modules
Precision to PMDA format and lifecycle
eCTD Conversion with Japanese Vocabulary
Freya aligns Japanese terminology & folder structure per PMDA guidelines
Generic eCTD; no Japan-specific vocabulary alignment
Ensures PMDA-acceptable dossier structure
PMDA-Compliant Validation Tools
SUBMIT PRO supports Japanese DTD formats, eCTD v4.0, and detects up to 800 errors
Tools, either backend or generic, are not clearly Japan-compliant
Higher submission accuracy and success rate
FMA (Foreign Manufacturer Accreditation)
Offers full documentation assistance, in-country caretaker appointment via Japanese affiliate
Typically not addressed in standard RIM offerings
Comprehensive compliance readiness
Local Representative & QMS Advisory
Provides in-country coordination, GMP gap analysis, and audit support for PMDA inspections
Often outsourced or unavailable; limited QMS advisory
Fully integrated support, including audits
Label & Package Insert Compliance
Translates and localizes packaging materials to PMDA standards via in-house service
Translation outsourced; formatting compliance variable
Holistic submission readiness
Lifecycle Query & Resubmission Management
Tracks PMDA inquiries, supports resubmissions via SUBMIT PRO and Japanese affiliate
The PMDA lifecycle often does not include separate tracking required
Smoother post-submission flow

Success Stories

  • 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

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Freyr Compliance Wall

Freyr Compliance Wall

Frequently Asked Questions

What are the key requirements for a successful PMDA submission in Japan?
A complete Japanese CTD, a robust clinical data package (including Japanese and foreign data), and clinical trial and pre-NDA consultations with PMDA are essential for approval. eCTD is already a de facto requirement, and v4.0 will become mandatory in April 2026.
How long does the PMDA review and approval process typically take?
Standard review in Japan takes 12–18 months, but expedited pathways like Sakigake or Conditional Approval can significantly shorten timelines.
What is the role of a DMAH in Japan?
A DMAH is legally required for foreign companies to market in Japan and handles submissions, recalls, safety reporting, and compliance. Freyr can act as or support your DMAH partner.
Are English-language submissions accepted by PMDA?
Japanese is still required for Modules 1 and 2 wholly, but Modules 3, 4, and 5 are available in English. Accurate localization remains critical.
What is the role of PMDA consultations, and when should they be scheduled?
Consultations are essential during development, submission, and post-approval to align on requirements. Freyr manages preparation and engagement.
How do GQP and GMP differ in Japan?
GMP covers manufacturing controls, and GQP governs post-manufacturing quality assurance. Both require PMDA audits, and Freyr ensures end-to-end compliance.
Are local clinical trials required if foreign data is available?
Not always. Japan may accept foreign data if it suits the local population. Bridging studies are often needed for new molecules.
What types of special designations are available in Japan?
Japan offers Orphan Drug, Sakigake, and Conditional Approval pathways, which provide faster reviews, incentives, and extended exclusivity.