Life Sciences Translation and Localization Services

Q: How do I translate clinical trial documents to comply with FDA and EMA requirements?

To translate clinical trial documents for FDA and EMA compliance, use qualified medical translators, maintain consistent terminology, and follow a documented quality review process. Clinical trial protocols, informed consent forms, investigator brochures, patient materials, and regulatory submissions should be translated with subject-matter expertise, version control, and terminology management to reduce compliance risk and support global trial execution.

Q: What languages do I need for EU drug submission dossiers?

The languages required for EU drug submission dossiers depend on the approval pathway and target markets. For centralized procedures, core scientific review may occur through the EMA, but product information, labeling, and patient-facing materials generally need translation into the official languages of the applicable EU member states. A qualified life sciences translation partner can help determine language requirements by country, document type, and regulatory pathway.

Q: How do I find a certified translation provider for IND applications?

To find a certified translation provider for IND applications, look for a language services partner with life sciences expertise, experience with FDA-facing documents, documented quality processes, and the ability to provide certificates of accuracy when required. The provider should understand clinical and regulatory terminology, manage translation memory and terminology glossaries, and support audit-ready workflows for Investigational New Drug application materials.

Q: What is ICH E6 R2 and does it affect how I manage translated GCP documents?

ICH E6 R2 is a Good Clinical Practice guideline that emphasizes quality management, sponsor oversight, documentation, and data integrity in clinical trials. It affects translated GCP documents because sponsors need controlled, traceable processes for managing clinical trial content across languages. Translated documents should be version-controlled, consistently reviewed, and aligned with approved source materials to support inspection readiness and patient safety.

Q: What are best practices for translating informed consent forms across multiple countries?

Best practices for translating informed consent forms include using native-speaking medical translators, adapting content for patient readability, maintaining consistency with the approved protocol, and conducting in-country review when appropriate. For multi-country trials, sponsors should also manage terminology centrally, control document versions, and ensure each translation reflects local language, cultural expectations, and regulatory requirements.

Q: How do I localize pharma brand messaging for LATAM vs. APAC markets?

To localize pharma brand messaging for LATAM and APAC markets, adapt more than the words. Messaging should reflect local regulations, cultural norms, healthcare systems, patient expectations, and approved claims in each market. A strong localization process keeps the global brand consistent while tailoring tone, terminology, and market-specific language for regional audiences.

Rapport International provides ISO 17100 and ISO 13485 aligned translation services for life sciences companies, covering clinical trial documentation, regulatory submissions (FDA, EMA, PMDA, NMPA), instructions for use, labeling, and patient-facing materials in 200+ languages. Submission-ready translations that meet 21 CFR Part 11, EU MDR 2017/745, IVDR 2017/746, and ICH E6 (R2) GCP requirements.

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Regulatory-Focused Accuracy

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Human Expertise + Process Control

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Terminology Consistency Across Documents

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Over 200 Languages Covered

Built for Regulatory, Clinical, and Quality Teams

In life sciences, language isn’t a final step — it’s a critical control point. Our approach aligns with the needs of:

Regulatory Affairs | Clinical Operations | Quality & Compliance | Global Market Access Teams

Whether you're preparing IFUs, clinical trial materials, labeling, or regulatory submissions, our team ensures your content is accurate, compliant, and ready for global market access. Our linguists combine life sciences expertise with regulatory precision to ensure your message is clearly understood across every market and stakeholder.

Medical Device and Pharmaceutical Documentation

Scientific Research & Regulatory Documentation

Institutional Review Board (IRB) Reports

Clinical Research Documents

Clinical Trial Forms and Documents

Patient Diaries, Consent Forms, and Related Materials

Patient Education and Healthcare Communications

Product Label & Packaging

Training Manuals and Handbooks

Specialized Translation for Medical Devices, Clinical Trials, and Pharma

Medical Device Translations

Irrevocable consequences can occur if important documents are not translated with absolute accuracy. And all your materials – patient information leaflets (IFUs/DFUs), regulatory documentation, packaging labels, and the like – must reach linguistically diverse markets. Our translations are done by experienced professionals, not software, to guarantee accuracy in your global markets.

Medical Device Translations

Clinical Trial Translations

Clinical trial documentation runs the full gamut, from legal patents and contracts to patient authorization forms and educational pamphlets. In every instance, the translation needs to be clear, accurate, precise, and easy to read. Our linguists have a deep understanding of patients’ cultural norms and your industry to make sure translations are proper and effective and adhere to your specifications and requirements.

Clinical Trial Translations

Biotech & Pharmaceutical Translations

Throughout each development phase – concept, development and research, clinical trials, regulatory processing, and distribution – accurate communication ensures a diverse trial pool and a skillful product launch into international markets. Our professional translators and interpreters have the skills and experience to deliver high-quality services that are culturally appropriate, on time and on budget, no matter where you are in the process.

Biotech Translations

Pricing for Translation Services

Our all-inclusive pricing starts at $0.21 per word with a minimum charge of $95.

Translation rates always include:

Linguistic Matchmaking
Consistency of Voice
Cultural Adaptation
Dedicated Support Team
Project Management
100% Satisfaction Guarantee
Proofreading
Process Improvement Advice
Cost Savings Recommendations
Version Quality Control

Beware of hidden charges when comparing costs.

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Project Discounts

Factors contributing to reduced fees include:

High Volume Orders
Large Projects
Retainer Services
Special Packages
Loyalty Discounts
Referrals
Long-Term Commitments

Add-On Services

Additional charges may be applied to projects that involve:

Rushed Deadlines
Editing by Second Translator
Foreign Language Desktop Publishing & Layout
Complex Projects or Highly Technical Subject Matter
Website Uploads or Updates
Localization or Transcreation
Certified Translations & Notarized Documents

FAQs

How do I translate clinical trial documents to comply with FDA and EMA requirements?

To comply with FDA and EMA requirements, clinical trial translations must be accurate, consistent, and aligned with regulatory terminology. This includes using qualified medical linguists, maintaining validated translation workflows, and ensuring consistency across protocols, ICFs, and submissions through centralized terminology management and quality review processes.

What languages do I need for EU drug submission dossiers?

EU drug submissions typically require translation into the official language(s) of each target member state where approval is sought. While EMA coordinates centralized procedures, labeling and patient-facing materials must be translated into all applicable EU languages to ensure compliance and accessibility at the national level.

How do I find a certified translation provider for IND applications?

Look for a provider with proven experience supporting IND applications, including familiarity with FDA expectations, Life Sciences subject-matter expertise, and documented quality processes (e.g., ISO-aligned workflows). The provider should offer audit trails, terminology management, and the ability to scale across multiple studies and languages.

What is ICH E6 R2 and does it affect how I manage translated GCP documents?

ICH E6 R2 is a global standard for Good Clinical Practice that emphasizes quality systems, data integrity, and oversight. It directly impacts translation by requiring documented processes, version control, and consistency across all translated clinical documents to ensure accuracy and traceability throughout the trial lifecycle.

Best practices for translating informed consent forms across multiple countries?

Informed consent forms should be translated using native, medically trained linguists and reviewed for cultural and linguistic appropriateness—not just literal accuracy. Best practices include back-translation, in-country review, and ensuring readability for patients, as well as maintaining consistency with the approved clinical protocol and regulatory language.

How do I localize pharma brand messaging for LATAM vs. APAC markets?

Effective localization goes beyond translation to adapt messaging for cultural, regulatory, and linguistic differences across LATAM and APAC. This includes adjusting tone, claims, and terminology to meet local regulations and audience expectations, while ensuring global brand consistency through centralized strategy and in-market expertise.

Award Winning Translation and Interpreting Services

What Our Life Science Clients Say About Us

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Our experience working with Rapport International has been excellent. Even with requests for large amounts of multiple language translations they’re always able to come through.

I've always recommended Rapport International to friends and colleagues and will continue to do so.

- Creative Services Manager, Gerson

I so appreciate the great service. Ranfac has counted on Rapport International for over a decade and looks forward to our next project together.

- EVP and GM, Ranfac

I really appreciate how Rapport International guides us in the most effective way to handle our translation and editing projects. We have to be accurate and on-time since we work with Information and Consent Forms for pharmaceutical clinical research trials.

We know that we can depend on Rapport International to deliver what we need in the best way possible.

- Asentral Institutional Review Board

Language of Global Marketing

Speaker - Global Business