Regulatory Affairs Translation
Expert translation for global regulatory submissions. CTD modules, product labeling, and compliance documentation for FDA, EMA, and worldwide agencies.
Global Regulatory Submission Support
Regulatory translation requires precision, consistency, and deep expertise in pharmaceutical and medical device terminology. Our specialized regulatory translators have extensive experience with FDA, EMA, PMDA, Health Canada, and other regulatory agency requirements.
From CTD dossiers to product labeling, we provide accurate translations that meet the specific formatting and content requirements of each target market.
CTD Module Translation
Complete translation support for all Common Technical Document 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 of product labeling documents that meet local regulatory requirements and language conventions.
SmPC (Summary of Product Characteristics)
- Full SmPC translation
- Section-specific updates
- QRD template compliance
- Consistency with approved text
PILs (Patient Information Leaflets)
- Clear, 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
Our translations are accepted by major regulatory agencies worldwide.
Frequently Asked Questions
Do you translate full CTD dossiers?
Yes, we translate complete CTD dossiers including all five modules. We also handle partial translations, updates, and variations. Our translators have extensive experience with the technical and scientific content in each module.
How do you ensure regulatory compliance in translations?
Our regulatory translators are trained in the specific requirements of each target agency. We use agency-specific terminology databases, adhere to QRD templates where applicable, and maintain consistency with previously approved texts.
Can you handle urgent regulatory submissions?
Yes, we offer expedited services for urgent regulatory submissions with turnaround as fast as 48 hours depending on document length and complexity. Our 24/7 project management ensures continuous progress on critical timelines.
Do you provide certified translations for regulatory submissions?
Yes, all regulatory translations include translation certificates suitable for submission to FDA, EMA, and other regulatory agencies. We maintain complete audit trails and documentation as required.
Request a Regulatory Translation Quote
Get a customized quote within 2 hours during business hours. Our team will assess your requirements and provide a detailed proposal.
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