Regulatory Affairs Translation
Expert translation for global regulatory submissions. CTD modules, product labeling, and compliance documentation.
Global Regulatory Submission Support
Our specialized regulatory translators have extensive experience with FDA, EMA, PMDA, Health Canada, and other agency requirements.
From CTD dossiers to product labeling, we provide accurate translations meeting each market's requirements.
Every regulatory market sets its own expectations for terminology, formatting, and source-document fidelity. Our regulatory linguists work from approved glossaries and agency style conventions, and our quality process pairs subject-matter translation with independent review so your dossiers, labeling, and lifecycle variations stay consistent and submission-ready across every jurisdiction.
CTD Module Translation
Complete support for all CTD modules.
Regional Administrative Information
- Cover letters
- Application forms
- Product information
- Labeling
CTD Summaries
- Quality Overall Summary
- Nonclinical Overview
- Clinical Overview
- Nonclinical & Clinical Summaries
Quality Documentation
- Drug substance info
- Drug product info
- Manufacturing process
- Control of excipients
Nonclinical Study Reports
- Pharmacology studies
- Pharmacokinetics
- Toxicology studies
- Study reports
Clinical Study Reports
- Clinical study reports
- Tabular listings
- Case report forms
- Literature references
Post-Approval Changes
- Type IA/IB variations
- Type II variations
- Extensions
- Renewals
Product Labeling Translation
Accurate translation meeting local regulatory requirements.
SmPC
- Full SmPC translation
- Section-specific updates
- QRD template compliance
- Consistency with approved text
PILs
- Patient-friendly language
- Readability testing support
- User testing documentation
- Layout and formatting
IMP Labels
- Primary container labels
- Secondary packaging
- Blinding labels
- Multi-language labels
Regulatory Agencies Supported
Translations accepted by major agencies worldwide.
What You Receive
Every regulatory translation project is delivered with the documentation and quality assurance your submission teams and reviewers expect.
Submission-Ready Translations
Fully formatted, agency-aligned translations of your CTD modules, labeling, and supporting documents, ready to drop into your dossier.
Terminology & Style Compliance
Translations produced with approved glossaries, QRD templates, and market-specific style conventions for consistent regulatory language.
Linguistic Review Sign-off
Independent in-country review of every translation, documenting that the content is accurate, complete, and fit for regulatory use.
Certificate of Accuracy & Audit Trail
A signed certificate of translation accuracy plus a complete version history and audit trail for your regulatory records.
Frequently Asked Questions
Do you translate full CTD dossiers?
Yes, all five modules plus variations and updates.
How do you ensure regulatory compliance?
Agency-specific terminology databases, QRD templates, and consistency with approved texts.
Can you handle urgent submissions?
Yes, expedited services with 48-hour turnaround available.
Do you provide certified translations?
Yes, all translations include certificates suitable for regulatory submission.
Request a Regulatory Translation Quote
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