Our pharmaceutical translations comply with FDA 21 CFR Parts 201, 312, and 11; ICH E6(R3) GCP; ICH M4 CTD format; EMA Clinical Trials Regulation (EU) 536/2014; PMDA submission requirements; and ISO 17100:2015 translation quality standards. Every project is documented with a full audit trail.
Pharmaceutical & Biotech
Pharmaceutical & BiotechTranslation Services
Regulatory-grade language services for pharmaceutical and biotech companies across the full drug development lifecycle — from IND filing through NDA submission, post-market surveillance, and global lifecycle management in 500+ languages.
ISO 17100 CertifiedFDA · EMA · PMDA500+ Languages
ISO 27001 information security · HIPAA-aligned · GSA-approved vendor
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Documents Translated
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Pharma Clients
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On-Time Delivery
Our Services
Translation across the full pharmaceutical lifecycle.
From early-phase IND submissions to post-market safety reporting, we cover every document type in the pharmaceutical development lifecycle.
IND / NDA / BLA
Regulatory Dossiers
Complete translation of IND, NDA, BLA, and CTD/eCTD dossiers for FDA, EMA, PMDA, and Health Canada submissions. Full audit trail and version control included.
Labeling
Drug Labeling & Package Inserts
Prescribing information, patient package inserts, and medication guides translated to meet FDA 21 CFR Part 201, EMA, and local labeling requirements worldwide.
Pharmacovigilance
Safety Reports (DSUR / PSUR / SUSAR)
Development Safety Update Reports, Periodic Safety Update Reports, and Suspected Unexpected Serious Adverse Reactions translated with 24/7 urgent turnaround capability.
Clinical
Investigator Brochures
Comprehensive IB translation and updates throughout the clinical development program, maintaining consistency with the master IB and all prior versions.
PRO / COA
Patient Reported Outcomes
ISPOR-compliant linguistic validation of PRO instruments, eCOA platforms, and patient diaries — forward translation, back-translation, and cognitive debriefing.
CMC
CMC Documentation
Chemistry, Manufacturing, and Controls documentation including drug substance and drug product specifications, analytical methods, and stability reports.
Regulatory
Health Authority Correspondence
Translation of FDA Complete Response Letters, EMA Day 120/180 responses, PMDA queries, and all health authority communications with rapid turnaround.
Post-Market
Post-Market Surveillance
Periodic Benefit-Risk Evaluation Reports (PBRERs), Risk Management Plans (RMPs), and post-approval change documentation for global lifecycle management.
Regulatory Compliance
Built for global regulatory requirements.
Every pharmaceutical translation we produce is designed to meet the specific requirements of the target regulatory authority.
FDA 21 CFR
US Food & Drug Administration
Full compliance with FDA requirements for drug labeling (21 CFR Part 201), clinical investigations (21 CFR Part 312), and electronic submissions (21 CFR Part 11).
ICH Guidelines
International Council for Harmonisation
Adherence to ICH E6(R3) GCP, ICH E3 (CSR structure), ICH M4 (CTD format), and ICH E2A–E2F pharmacovigilance guidelines across all document types.
EMA Regulations
European Medicines Agency
Compliance with EMA Clinical Trials Regulation (EU) 536/2014, EPAR requirements, and the EU pharmacovigilance framework including PSUR submissions.
PMDA Standards
Japan Pharmaceuticals & Medical Devices Agency
Japanese regulatory submissions meeting PMDA requirements, including Japanese-language CTD dossiers, labeling, and pharmacovigilance reports.
ISO 17100:2015
Translation Quality Standard
All translations produced under ISO 17100 processes — qualified translator, independent reviewer, and project manager — with full audit documentation.
HIPAA / GDPR
Data Privacy Compliance
All patient data, clinical information, and proprietary drug information handled under HIPAA-compliant and GDPR-compliant data security protocols.
Why Day Translations
The pharmaceutical translation partner for global drug development.
Pharmaceutical translation is among the most demanding disciplines in the language services industry. A single mistranslation in a drug label, a pharmacovigilance report, or a clinical trial protocol can result in patient harm, regulatory rejection, or costly program delays. Day Translations has built a dedicated pharmaceutical translation practice for nearly two decades, assembling teams of linguists who hold advanced degrees in pharmacology, medicine, biochemistry, and regulatory affairs.
Our pharmaceutical translation workflow is built around the ICH E6(R3) Good Clinical Practice framework and ISO 17100:2015 quality standards. Every document undergoes a two-step translation and independent review process, with a third-party reconciliation step for critical documents such as informed consent forms and drug labels. We maintain client-specific Translation Memories and glossaries that ensure terminology consistency across all documents in a program — from the first IND filing through final NDA submission.
For global pharmaceutical programs, we provide centralized project management with regional linguistic expertise. Our teams cover all major regulatory markets — FDA (US), EMA (EU), PMDA (Japan), Health Canada, TGA (Australia), ANVISA (Brazil), and NMPA (China) — with linguists who understand the specific formatting, terminology, and submission requirements of each authority.
Key Capabilities
- CTD/eCTD Modules 1–5 translation & formatting
- Dedicated pharma linguist teams per therapeutic area
- Translation Memory & terminology management systems
- Back-translation with reconciliation reports
- 24/7 urgent pharmacovigilance turnaround
- FDA 21 CFR Part 11 compliant audit trails
- Certified translations with notarization available
- Multi-market simultaneous submission support
Who We Serve
Serving the full pharmaceutical ecosystem.
Pharmaceutical Sponsors
Global pharma companies and emerging biotech sponsors advancing novel therapeutics through FDA, EMA, and PMDA regulatory pathways.
- IND, NDA, BLA, MAA dossier translation
- Drug labeling & prescribing information
- Pharmacovigilance safety reports
- Post-approval lifecycle management
- Global regulatory submission programs
Contract Research Organizations
CROs managing global Phase I–IV studies requiring consistent, audit-ready translations across all study sites and regulatory markets.
- Protocol & amendment translations
- Site activation package localization
- Clinical Study Report (CSR) translation
- Regulatory submission support
- 24/7 project management
Biotech & Gene Therapy Companies
Emerging biotech and gene therapy companies navigating complex regulatory landscapes for novel biologics, cell therapies, and ATMPs.
- ATMP regulatory documentation
- Gene therapy IND/CTA filings
- Biologics License Application (BLA)
- Companion diagnostic documentation
- Orphan drug designation applications
Our Process
Six-step pharmaceutical translation process.
01
Intake & Document Analysis
Regulatory specialist reviews document type, target authority, language pairs, and therapeutic area to assign the optimal linguist team.
02
Glossary & TM Alignment
Client-specific Translation Memory and approved terminology glossary are loaded. New terms are flagged for client approval before translation begins.
03
Expert Translation
Qualified translator with relevant scientific/regulatory background produces the translation, applying all TM matches and approved terminology.
04
Independent Review
A second qualified linguist independently reviews the translation for accuracy, consistency, and regulatory compliance — per ISO 17100 requirements.
05
QA & Formatting
Quality assurance review checks formatting, completeness, and regulatory compliance. DTP team reformats to match source document layout if required.
06
Delivery & Certification
Final document delivered with Certificate of Translation, audit trail, and TM update. Notarization and apostille available on request.
FAQ
Frequently asked questions.
Yes. We provide full back-translation services with reconciliation reports for drug labels, informed consent forms, patient information leaflets, and other critical documents. Our back-translation process follows FDA and ICH guidance, with a qualified translator producing the back-translation independently from the forward translation, followed by a side-by-side reconciliation review.
We maintain 24/7 availability for urgent pharmacovigilance documents. SUSARs are typically turned around within 24 hours, with expedited options available for same-day delivery. We have dedicated pharmacovigilance linguist teams on standby for each major language pair, ensuring that safety signals reach regulatory authorities within required timelines.
Yes. We specialize in multi-market simultaneous submissions and have managed programs covering FDA, EMA, PMDA, Health Canada, TGA, and NMPA in parallel. We use centralized Translation Memory systems and terminology databases to ensure consistency across all modules and all target markets, with a single project manager coordinating the entire program.
We create and maintain client-specific Translation Memories (TMs) and approved terminology glossaries for each drug development program. All new translations leverage existing TM matches, and any new terms are flagged for client approval before being added to the glossary. This ensures that terminology remains consistent from the first IND filing through final NDA submission and post-market surveillance.
Yes. All pharmaceutical translators on our team hold advanced degrees in pharmacology, medicine, biochemistry, regulatory affairs, or a related discipline. We do not use general translators for pharmaceutical documents. Translators are also required to have a minimum of five years of pharmaceutical translation experience and undergo regular continuing education in regulatory affairs.
Yes. We provide certified translations with a Certificate of Translation for all regulatory submissions. The certificate attests to the accuracy and completeness of the translation and includes the translator's qualifications. Notarization and apostille services are also available for documents requiring official authentication.
All pharmaceutical projects are handled under strict confidentiality agreements, including mutual NDAs. We use encrypted file transfer (AES-256), role-based access controls, and secure project management platforms. Our information security practices are aligned with ISO 27001, and we execute Business Associate Agreements (BAAs) for HIPAA-covered information. All staff undergo annual data security training.
Ready to advance your pharmaceutical program?
Contact our pharmaceutical translation specialists. We respond within 15 minutes during business hours.
Explore More
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Pharmaceutical and biotech translation is one part of the life sciences spectrum. Day Translations supports the full drug development, safety, and regulatory lifecycle.
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Clinical Trial Translation Services
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Safety
Drug Safety & Pharmacovigilance
DSURs, SUSARs, PSURs, and ICSRs translated 24/7 with zero ambiguity.
Regulatory
Regulatory Affairs Translation
CTD/eCTD dossiers, health authority correspondence, and risk management plans.
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