We cover all major global regulatory authorities including FDA (US), EMA (EU), PMDA (Japan), Health Canada, TGA (Australia), ANVISA (Brazil), NMPA (China), MFDS (South Korea), Swissmedic (Switzerland), and many others. We have dedicated regulatory translation teams for each major market with linguists who understand the specific submission requirements of each authority.
Regulatory Affairs
Regulatory AffairsTranslation Services
Day Translations provides regulatory affairs translation specialists who work directly with RA teams to ensure dossiers, correspondence, and labeling meet the precise requirements of FDA, EMA, PMDA, Health Canada, TGA, ANVISA, and NMPA.
ISO 17100 CertifiedFDA · EMA · PMDACTD/eCTD Specialists
ISO 27001 information security · HIPAA-aligned · GSA-approved vendor
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Regulatory Documents
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RA Clients
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On-Time Delivery
Our Services
Regulatory affairs translation services.
Specialized translation for every document type in the regulatory affairs sector.
CTD/eCTD
CTD/eCTD Dossier Translation
Complete translation of Common Technical Document Modules 1-5 for FDA, EMA, PMDA, and Health Canada submissions, with formatting to meet each authority's specific requirements.
FDA
FDA Submission Translation
IND, NDA, BLA, ANDA, and 505(b)(2) application translation for FDA CDER and CBER, including complete response letters and labeling supplements.
EMA
EMA Marketing Authorization
MAA, IMPD, and EPAR translation for EMA centralized procedure, including Day 120/180 responses and post-approval variation documentation.
PMDA
PMDA Japan Submissions
Japanese-language CTD dossiers, labeling, and pharmacovigilance reports for PMDA submissions, including SAKIGAKE designation applications.
Labeling
Regulatory Labeling & Artwork
Drug labels, package inserts, and prescribing information translated to meet FDA 21 CFR Part 201, EMA Annex II, and local labeling requirements worldwide.
Correspondence
Health Authority Correspondence
Translation of FDA Complete Response Letters, EMA Day 120/180 responses, PMDA queries, and all health authority communications with rapid turnaround.
Risk Mgmt
Risk Management Plans
EU Risk Management Plans (RMPs), FDA Risk Evaluation and Mitigation Strategies (REMS), and PMDA risk management documentation translated for global submissions.
Post-Approval
Post-Approval Change Submissions
Type IA/IB/II variation translations for EMA, CBE/PAS supplements for FDA, and post-approval change documentation for all global regulatory markets.
Regulatory Compliance
Built for global regulatory requirements.
Every translation is designed to meet the specific requirements of the target regulatory authority.
FDA 21 CFR
US Federal Regulations
Comprehensive coverage of FDA regulations including 21 CFR Parts 201 (labeling), 312 (IND), 314 (NDA), 601 (BLA), and 11 (electronic records) for all submission types.
ICH M4 CTD
Common Technical Document
ICH M4 guidelines governing the CTD format for regulatory submissions to FDA, EMA, PMDA, and Health Canada — ensuring consistent structure across all global dossiers.
EMA Regulations
European Medicines Agency
EU pharmaceutical legislation including Directive 2001/83/EC, Regulation (EC) 726/2004, and Clinical Trials Regulation (EU) 536/2014 for all European submissions.
PMDA Guidelines
Japan Pharmaceuticals Agency
PMDA submission requirements for new drug applications, including Japanese-language CTD formatting, labeling standards, and pharmacovigilance reporting.
ICH E2A-E2F
Pharmacovigilance Guidelines
ICH pharmacovigilance guidelines governing SUSAR reporting, DSUR/PSUR structure, and signal detection — applicable to all global safety reporting obligations.
ISO 17100:2015
Translation Quality
All regulatory translations produced under ISO 17100 processes with qualified translator, independent reviewer, and project manager — full audit documentation provided.
Why Day Translations
The regulatory affairs translation partner trusted globally.
Regulatory affairs translation is the most consequential discipline in the life sciences language services industry. A single mistranslation in a regulatory submission can result in a Complete Response Letter, a clinical hold, or a market withdrawal — consequences that can cost hundreds of millions of dollars and delay patient access to life-saving therapies. Day Translations has built a dedicated regulatory affairs translation practice staffed by linguists who hold advanced degrees in regulatory science, pharmacology, medicine, and pharmaceutical sciences.
Our regulatory translation specialists understand the nuances of global submission requirements in ways that general translators cannot. They know that FDA Module 1 labeling requirements differ from EMA Annex II, that PMDA has specific formatting requirements for Japanese-language CTD dossiers, and that Health Canada's Common Technical Document requirements include specific Canadian labeling provisions. This regulatory intelligence is embedded in every translation we produce.
For multi-market simultaneous submissions, Day Translations provides centralized program management with regional linguistic expertise. We have managed global submission programs covering FDA, EMA, PMDA, Health Canada, TGA (Australia), ANVISA (Brazil), NMPA (China), and MFDS (South Korea) in parallel — using shared Translation Memories and terminology databases to ensure consistency across all markets and all modules.
Our regulatory translation practice also covers the full post-approval lifecycle. We translate Type IA/IB/II variations for EMA, CBE/PAS supplements for FDA, and post-approval change documentation for all global markets. We provide rapid turnaround for health authority responses — FDA Complete Response Letters, EMA Day 120/180 responses, and PMDA queries — with dedicated regulatory linguist teams on standby for urgent submissions.
Key Capabilities
- CTD/eCTD Modules 1-5 translation & formatting
- Multi-market simultaneous submission programs
- FDA CRL and health authority response translation
- EMA Day 120/180 response translation
- PMDA Japanese-language CTD dossiers
- Risk Management Plan (RMP/REMS) translation
- Post-approval variation and supplement translation
- Regulatory labeling and artwork translation
Who We Serve
Serving the full regulatory affairs ecosystem.
Pharmaceutical Sponsors
Global pharma and biotech companies requiring regulatory translation for multi-market drug development programs from IND through NDA/MAA and post-market.
- CTD/eCTD dossier translation
- Multi-market simultaneous submissions
- Health authority response translation
- Post-approval variation translation
- Regulatory labeling & artwork
Regulatory Affairs Consultancies
RA consulting firms supporting pharmaceutical clients through global regulatory submissions, health authority interactions, and lifecycle management.
- Regulatory strategy document translation
- Health authority meeting minutes
- Scientific advice request translation
- Regulatory intelligence reports
- Dossier gap analysis translation
Generics & Biosimilars Companies
Generic drug and biosimilar manufacturers requiring ANDA, ASMF, and biosimilar regulatory submission translation for FDA, EMA, and global markets.
- ANDA and 505(b)(2) submissions
- Biosimilar BLA/MAA translation
- ASMF/DMF translation
- Bioequivalence study reports
- Reference product dossier translation
Our Process
Six-step regulatory affairs translation process.
01
Regulatory Pathway Assessment
RA specialist reviews submission type, target authority, and timeline to assign regulatory translation specialists with matching expertise.
02
Dossier & Terminology Setup
Client CTD structure analyzed, existing TM loaded, and regulatory glossary established per target authority requirements.
03
Expert Regulatory Translation
Regulatory affairs specialist produces translation with full compliance to CTD format and target authority requirements.
04
Independent Regulatory Review
Second qualified RA linguist independently reviews for regulatory accuracy, terminology consistency, and format compliance.
05
QA & Format Verification
QA review verifies CTD module structure, cross-references, and formatting against target authority specifications.
06
Certified Delivery & Archiving
Final dossier delivered with Certificate of Translation, full audit trail, and TM update for future submissions.
FAQ
Frequently asked questions.
Yes. We specialize in multi-market simultaneous CTD/eCTD submissions and have managed programs covering FDA, EMA, PMDA, Health Canada, and other markets in parallel. We use centralized Translation Memories and terminology databases to ensure consistency across all modules and all target markets, with a single program manager coordinating the entire submission.
We maintain dedicated regulatory linguist teams on standby for urgent health authority responses. FDA Complete Response Letter responses and EMA Day 120/180 responses are typically turned around within 5-10 business days depending on volume. Expedited turnaround is available for time-critical submissions, with same-day delivery possible for shorter documents.
Yes. We have a dedicated PMDA translation team with linguists who hold advanced degrees in pharmaceutical sciences and regulatory affairs and have direct experience with PMDA submission requirements. We translate Japanese-language CTD dossiers, labeling, pharmacovigilance reports, and SAKIGAKE designation applications.
We create and maintain client-specific Translation Memories and approved regulatory terminology glossaries for each drug development program. All translations leverage existing TM matches, and new terms are flagged for client approval before being added to the glossary. This ensures that regulatory terminology remains consistent from the first IND filing through final NDA/MAA submission and all post-approval variations.
Yes. We translate EU Risk Management Plans (RMPs) for EMA submissions and FDA Risk Evaluation and Mitigation Strategies (REMS) documentation. Our RA specialists understand the specific content requirements for RMPs under EU pharmacovigilance legislation and REMS under FDA FDAAA, ensuring that safety information is translated with the precision required for regulatory review.
Yes. We translate Type IA, IB, and II variations for EMA, CBE and PAS supplements for FDA, and post-approval change documentation for all global regulatory markets. We maintain existing TMs and glossaries from the original submission to ensure consistency in all post-approval documentation.
Yes. All regulatory translations are provided with a Certificate of Translation attesting to the accuracy and completeness of the translation. The certificate includes the translator's qualifications and is accepted by FDA, EMA, PMDA, and other global regulatory authorities. Notarization and apostille services are also available for documents requiring official authentication.
Ready to advance your regulatory affairs program?
Contact our regulatory affairs translation specialists. We respond within 15 minutes during business hours.
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