Japanese Regulatory Translation Services
Contents
Japanese regulatory translation for compliance submissions
24 Hours Translate provides 100% human-based, accurate Japanese regulatory translation services for drug making, life sciences, healthcare, and other regulated industries.
We help organizations manage the complexity and diversity of regulatory requirements across jurisdictions, as well as cultural and language barriers—especially in multi-region operations.
Our work is delivered by native regulatory translators, editors, and domain specialists, supported by multi-step quality workflows to ensure consistent terminology, accuracy, and regulatory precision.
Our processes align with PMDA and MHLW expectations, as well as FDA and EMA requirements, covering submission dossiers, approval documentation, technical files, and other high-stakes regulatory materials.
Certificates of Accuracy are available upon request, along with back-translation and linguistic validation services to support clarity, consistency, and audit-ready submissions. Contact us to get started today.
Certification & Statement of Accuracy for Japanese regulatory submissions
Statements of Accuracy are available upon request. We support clients with official submissions to regulatory authorities by providing Japanese translations of regulatory approval materials and other certified regulatory documentation, ensuring accuracy, completeness, and compliance at every stage.
Our delivery package includes:
- Signed Statement of Accuracy confirming the translation is complete and accurate to the best of our knowledge and professional standards
- Certification on company letterhead for use with regulatory authorities (e.g., FDA, EMA, PMDA), CROs, hospitals, academic institutions, courts, and other governmental bodies
- Signed translator declarations supporting regulatory submission requirements
- Back-translation services to verify accuracy and consistency of translated materials
- Linguistic validation services for regulatory-facing documentation
- Support for MDR-compliant documentation and other regulated use cases requiring audit-ready quality and traceability
Why choose us?
Regulatory Compliance Specialization
We work with a dedicated team of Japanese regulatory specialists who act as the navigators of complex medical, legal, and certified submission pathways.
We ensure that every document is accurately translated and aligned with both Japan-specific requirements and international regulatory expectations, supporting structured communication with authorities such as PMDA, MHLW, FDA, EMA, and MHRA.
Our specializations include:
- Terminology control across multilingual documentation
- Standardized regulatory formatting
- Preservation of regulatory intent
- Consistency across all materials
- Version traceability and document control
- Submission-ready output across the approval process
Human-Based Translation Solutions for High-Stakes Content
At 24 Hours Translate, we provide accurate, 100% human-based Japanese regulatory translation services, delivered by native-speaking regulatory translators with deep subject-matter expertise in regulated documentation and compliance-driven content.
We believe a human-based approach is essential for high-stakes regulatory content. Only qualified human linguists can accurately interpret complex terminology, apply regulatory context correctly, and ensure clarity across submission-ready documentation in Japanese.
Our translators work exclusively into their native language, ensuring outputs that are technically precise and culturally appropriate, supporting compliance with PMDA requirements and alignment with relevant regulatory standards in Japan and international markets.
Scalable Language Support for Global Regulatory Submissions
We are fully capable of scaling our regulatory translation services for international organizations handling complex, high-volume submission requirements across multiple global markets.
Our translators, regulatory specialists, and engineers can promptly adapt to both bespoke document needs and large-scale regulatory programs without compromising quality or accuracy.
We offer reliable support for submission packages, coordinated document updates, and multilingual regulatory requirements across authorities such as PMDA, MHLW, FDA, EMA, and MHRA—helping teams maintain efficiency while meeting strict regulatory expectations at scale.
Audit-Ready Deliverables for Regulated Industries
We provide structured regulatory translation and quality assurance processes designed to ensure audit-ready documentation across highly regulated industries and global submission environments.
As MDR and IVDR requirements continue to evolve, teams must prioritize accuracy, manage complexity, and maintain full control over multilingual regulatory content.
To support this, we apply:
- Controlled terminology across all translated content
- Standardized formatting for regulatory consistency
- Structured review processes to reduce variability
- Traceable documentation across all language versions
- Workflow design for high-volume regulatory content
- Strict quality controls to ensure accuracy and integrity
Secure and Confidential Handling of Sensitive Materials
24 Hours Translate is committed to maintaining the highest standards of data security and confidentiality, with a clear ethical and legal responsibility to protect all client-sensitive information.
We implement strict confidentiality agreements at every human touchpoint across each translation project. Our workflows are supported by experienced IT professionals, including cybersecurity specialists and information security experts, to help ensure continuous data protection.
We also use secure technologies to protect documents during transmission and storage, including email encryption, controlled access permissions, and additional security protocols designed to prevent unauthorized access and reduce data risk.
Japanese regulatory document types we translate
We specialize in Japanese regulatory translation services for a wide range of document types, including submission, compliance, technical, legal, and regulatory-facing documentation:
Instructions for Use (IFUs) and Technical Documentation
- Instructions for Use (IFUs)
- User manuals and operator guides
- Installation and maintenance instructions
- Device technical files and specifications
- Engineering, design, and safety documentation
- Verification and validation reports
- Clinical trial protocols
- Investigator brochures (IBs)
- Informed consent forms (ICFs)
- Clinical study reports and amendments
- Drug development and regulatory submission dossiers
- Pharmacovigilance and safety reports
IVD, Diagnostic, and Medical Software Documentation
- IVDR technical documentation
- Diagnostic device manuals and performance reports
- Validation and evaluation studies
- Software specifications and SaMD documentation
- User interface and system documentation
- Risk management documentation
Regulatory Submission and Approval Dossiers
- Regulatory submission dossiers
- Application forms and supporting documents
- Multi-document submission packages
- Trial Reference Documents
- Cross-reference and annex materials
- Authority-specific submission sets (PMDA, FDA, EMA)
Post-Market Surveillance and Compliance Reports
- Adverse event and safety reports
- Post-market surveillance (PMS) reports
- Periodic safety update reports (PSURs)
- Product lifecycle and compliance updates
- Ongoing regulatory maintenance documentation
- Field safety corrective action (FSCA) documentation
Quality, Risk, and Compliance Documentation
- Quality management system (QMS) documentation
- Risk management files and reports
- Audit and inspection documentation
- Compliance and certification records
- Regulatory correspondence and response documents
- SOPs and controlled document records
Regulatory compliance for Japan & global authorities
We provide controlled, audit-ready regulatory translation services aligned with the documentation requirements of PMDA (Japan), FDA (United States), and EMA (European Union), supporting multilingual submission and compliance documentation across international regulatory environments.
Alignment with PMDA Requirements
Our expert regulatory translators are trained to handle high-stakes Japanese submission documentation with accuracy, consistency, and compliance awareness.
They work with controlled terminology aligned with PMDA requirements, structured submission formatting, and rigorous quality processes designed for complex regulatory documents.
Bridging Japan, EU, and US Submissions
We support harmonized regulatory translation for organizations managing submissions across Japan, the EU, and the US.
Our approach helps maintain cross-border consistency in terminology, document version control, and multilingual filing traceability across global submission environments.
Step 1: Translation Request
We analyze the project details and requirements.
A dedicated project manager makes an initial evaluation of your regulatory translation project after analyzing your documents, word count, source and target languages, delivery date, purpose, submission regulations, and other requirements.
Step 2: Translation Preparation
We will begin preparing for any potential challenges by taking the necessary steps to identify and address them.
Once the contract has been signed, we will assemble a dedicated team of industry-specific translators who are native speakers of your target language, along with experienced editors and proofreaders. We will also prepare the latest field-specific glossaries and translation memories to ensure consistency, accuracy, and compliance throughout the project.
Step 3: Translation
After reading and evaluating your source documents, our translators will begin translating your content in an organized, detail-oriented manner. During translation, they will ensure that all technical terms and translation memories are applied accurately.
Step 4: Editing
Editors will review the translated texts to ensure they meet the project’s objectives, expectations, and applicable regulatory standards.
They will carefully examine the grammar, spelling, terminology, and sentence structure, while also verifying that the translation remains faithful to the original content, maintains the same level of writing quality, and complies with the submission requirements of the relevant regulatory authorities.
Step 5: Formatting
The formatting of the translated document will be adjusted so it matches the original.
Graphic designers or DTP (desktop publishing) professionals will handle the formatting of the translation so that it looks, feels, and functions like the original and serves the same purpose.
Step 6: Proofreading & Quality Assurance
A final proofreading and revision of the formatted texts in detail.
Proofreaders will review the formatted texts to avoid errors or inconsistencies. The final translated document will be faithful to the original, error-free, and meet the highest quality standards.
Step 7: Delivery & Database Update
After a final check, the project manager will deliver the project.
The project manager will deliver the finished documents to the client on time. The client’s translation memories and terminology base will be updated accordingly.
Certified translation for Japanese regulatory use
As a language service provider supporting regulated industries, we provide certified translation solutions for regulatory, legal, and compliance-related submissions that require a high level of accuracy and documentation integrity.
Our certified translation services help support official review, regulatory acceptance, and multilingual consistency across complex submission workflows.
Commonly used for:
- GMP certificates
- Corporate records
- Compliance documentation
- Clinical trial documentation
- Patient information leaflets
- Pharmacovigilance and safety documentation
- Manufacturing licenses
- Legal declarations
- Quality assurance records
- Informed consent forms (ICFs)
- Clinical study reports (CSRs)
- Medical device registration materials
Industries we support
Medical device and MedTech companies
- Device manufacturers preparing regulatory submissions for the Japanese market
- Companies managing technical documentation, IFUs, and compliance files
- Diagnostic and surgical device providers requiring approval-ready translation
Pharmaceutical and biotechnology companies
- Drug development and approval-focused organizations
- Teams preparing regulatory submission packages and supporting documentation
- Companies managing safety, quality, and lifecycle documentation
IVD and diagnostic technology providers
- In vitro diagnostic device manufacturers
- Companies preparing technical and performance documentation for submission
- Developers of diagnostic systems requiring compliance translation
Medical software and digital health companies
- Software as a Medical Device (SaMD) developers
- Digital health and AI-based diagnostic solution providers
- Companies preparing validation and system documentation
Clinical Research Organizations (CROs)
- Organizations managing multi-region clinical study documentation
- Teams supporting regulatory submissions and trial-related materials
- CROs coordinating documentation for Japan, EU, and US markets
Regulatory Affairs and Compliance Teams
- Internal regulatory departments in global life sciences companies
- Teams managing submission packages and cross-border documentation
- Compliance units ensuring consistency across regulatory filings
Language pairs we translate
We support a wide range of language pairs for regulatory translation projects across major Asian and European markets, enabling accurate and compliant documentation for global submissions and cross-border regulatory requirements.
Use Cases & Scenarios
1. Clinical Trial Start Submissions (CTA / IND)
- Scenario: Submissions to obtain approval to initiate clinical trials before first patient enrollment, including protocols, preclinical evidence, investigational product information, and ethics-related documentation.
- Solution: Accurate translation of full submission packages with attention to version alignment across protocol and supporting documents.
- Language pairs: Japanese → English and EU official languages
2. Marketing Authorization Applications (MAA / NDA / BLA)
- Scenario: Regulatory submissions for market approval involving expanded clinical evidence, quality/CMC documentation, and pharmacovigilance planning.
- Solution: Structured translation ensuring consistency across cross-referenced documents and multi-author submission packages.
- Language pairs: Japanese ↔ English, EU and Asian languages
3. Protocol Amendments and Substantial Modifications
- Scenario: Updates to ongoing clinical trials such as changes to eligibility criteria, endpoints, and safety monitoring requirements.
- Solution: Consistent translation of amended protocols and all impacted supporting documentation to ensure full document consistency.
- Language pairs: Japanese → English and multilingual regulatory documentation
4. Safety and Progress Submissions During Clinical Conduct
- Scenario: Periodic or triggered safety and progress reports during clinical trials, including annual reports and cumulative safety summaries.
- Solution: Accurate translation ensuring consistency between reported data cut-off points and source documentation.
- Language pairs: Japanese → English and EU official languages
5. Lifecycle Variations and Dossier Updates
- Scenario: Updates to approved regulatory dossiers, including changes to quality, CMC, labeling, or administrative content.
- Solution: Precise translation with full traceability across updated sections and regulatory documentation sets.
- Language pairs: Japanese ↔ English and global regulatory languages
6. Post-Approval Commitments and Post-Market Submissions
- Scenario: Ongoing regulatory obligations after approval, including post-market surveillance and commitment-related reporting.
- Solution: Precise translation ensuring traceability between commitments, execution, and submitted evidence.
- Language pairs: Japanese → English and additional regulatory languages
FAQs
Will your translations be accepted for PMDA submissions?
Yes, we provide specialized translation services for regulatory submission contexts, including documentation intended for PMDA review.
With a strong understanding of submission workflows, we focus on managed terminology practices, multi-step quality assurance, and alignment with regulatory expectations. Each project follows a compliance-first framework to support submission readiness and minimize the risk of rejection arising from linguistic inconsistencies.
Do you handle medical device and pharmaceutical documents for the Japanese market?
Yes. We regularly handle medical device and pharmaceutical documentation for the Japanese market, including materials used in regulatory submissions and approval processes. This includes:
- Instructions for Use (IFU)
- Technical files and device documentation
- Clinical trial protocols and related materials
- Regulatory submission dossiers
- Drug development and approval documents
- Safety and pharmacovigilance reports
Do you use human translators or machine translation?
Yes. All regulatory and compliance-related translations are handled by qualified human translators with experience in high-stakes and regulated documentation. No raw machine or automated translation is used in submission-critical content.
Can you support English–Japanese regulatory translation?
Yes. We support both English-to-Japanese and Japanese-to-English regulatory translation. We also support multilingual workflows involving major Asian and European languages for global compliance and submission documentation.
Who needs Japanese regulatory translation services?
Japanese regulatory translation services are commonly required by organizations preparing documentation for the Japanese market, including:
- Medical device manufacturers
- Pharmaceutical and biotechnology companies
- Clinical research organizations (CROs)
- IVD and diagnostic developers
- Medical software and SaMD companies
- Regulatory affairs and compliance teams
They are also widely used in multilingual submission and compliance workflows across Japan, the EU, and the US.
How do you ensure accuracy in regulatory documents?
We follow a controlled TEP (Translation, Editing, Proofreading) workflow designed for high-stakes regulatory content. Each document is translated by a qualified specialist, independently reviewed for accuracy and consistency, and proofread to ensure alignment with submission requirements.
Terminology is centrally managed across the project, and final quality checks are performed to support audit readiness and submission integrity.
Do you translate IFUs and technical files?
Yes. We translate Instructions for Use (IFUs), technical files, and related regulatory documentation used in medical device and compliance submissions. This includes device manuals, technical documentation, validation reports, and supporting materials required for regulatory approval and market entry, such as submissions to authorities including PMDA (Japan), FDA (United States), and EMA (European Union).
Can you meet urgent submission deadlines?
Yes. We have the linguistic team, experience, and expertise to support time-sensitive regulatory translation projects with prioritized workflows. Urgent assignments are managed through coordinated scheduling and controlled QA processes to ensure accuracy and consistency, even under tight global submission deadlines.
How do you handle confidential documents?
We handle all confidential materials through controlled, secure workflows designed for high-stakes documentation. This includes:
- Restricted access to authorized linguists and reviewers only
- Secure file transfer and controlled document handling processes
- NDA agreements available prior to project commencement
- Confidentiality maintained throughout the full translation lifecycle
- Strict separation of project files and client data to prevent cross-access
All processes are designed to protect sensitive information at every stage of the project.
What payment methods do you accept?
We support a wide range of secure and flexible payment options to make the translation process simple and reliable for global regulatory clients, including Japanese market submissions:
- PayPal for fast and secure international payments
- Payoneer for global cross-border business payments and multi-currency transfers
- Bank transfer for standard invoicing and corporate payments
- Multi-currency support: We accept payments in USD, EUR, and other major global currencies, enabling smooth cross-border transactions for Japanese regulatory translation projects
We work with clear, pre-agreed payment terms based on project scope, ensuring transparency and smooth financial processing for all regulatory submission and compliance projects worldwide.
Can you provide certified translation for regulatory submissions if required?
Yes. We can provide certified translations for regulatory submissions when formal certification is required for compliance, audit, or submission purposes. Each certified output includes a stamped Statement of Accuracy, the translator’s signed declaration, and signature, and is prepared in line with the requirements of relevant regulatory authorities, including PMDA (Japan), FDA (United States), and EMA (European Union).
