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Medical Translation Services

Specialized translation of pharmaceutical documentation, clinical trial protocols, patient records, and drug labels by linguists with medical and life-science backgrounds.

★★★★★ 4.9/5 20+ years 120+ languages ISO 9001

In medicine and pharmaceuticals, translation errors can have life-or-death consequences. A misinterpreted dosage instruction on a drug label, an ambiguous phrase in a clinical trial protocol, or an inaccurate patient consent form can endanger lives, trigger regulatory sanctions, and expose companies to massive liability. Medical translation is not a task for generalists — it demands translators who think like scientists and write like regulators.

At iTrex, our medical translation division employs linguists with advanced degrees in medicine, pharmacology, biochemistry, and related life sciences. Over 20+ years, we have translated millions of words of clinical documentation across 120+ languages for pharmaceutical companies, CROs, hospitals, medical device manufacturers, and regulatory agencies. From Phase I trial protocols to post-market surveillance reports, from FDA submissions to EU MDR technical files, we deliver translations that meet the exacting standards of every major health authority.

Every medical translation follows our ISO 9001-certified, GxP-aligned workflow: translation by a domain specialist, expert review by a second life-science linguist, and rigorous QA checks against source terminology databases. Combined with HIPAA-compliant data handling and full audit trails, iTrex is the partner pharmaceutical and healthcare organizations trust when accuracy is non-negotiable.

Key Features

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Life-Science Specialist Translators

Your medical documents are translated by professionals with degrees in medicine, pharmacology, or biomedical sciences. They understand clinical terminology, drug nomenclature (INN/USAN), and the regulatory language of FDA, EMA, and other health authorities.

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Regulatory Compliance Built In

We translate according to ICH guidelines, FDA 21 CFR Part 11 requirements, and EU MDR/IVDR standards. Our workflows are designed for GxP environments, ensuring audit-ready documentation with full traceability from source to target.

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HIPAA & Patient Data Security

Patient confidentiality is paramount. Our systems and processes comply with HIPAA, GDPR, and local data protection regulations. All translators sign BAAs, files are encrypted end-to-end, and PHI is handled under strict access controls.

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When You Need This

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Multinational Clinical Trial Documentation

A pharmaceutical company is launching a Phase III trial across 12 countries and needs investigator brochures, informed consent forms, and case report forms translated into 9 languages while maintaining ICH-GCP compliance in every version.

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Drug Labeling & Packaging for New Markets

Your company is launching a cardiovascular drug in Latin America and needs SmPC, PIL, and outer packaging text translated from English into Spanish and Portuguese, formatted to fit label dimensions and compliant with ANVISA and COFEPRIS requirements.

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Regulatory Submission Dossiers

A medical device manufacturer needs its CTD (Common Technical Document) modules translated from German to English for FDA 510(k) submission, including quality system documentation, biocompatibility studies, and clinical evaluation reports.

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Patient Records & Hospital Documentation

A patient relocating from the Middle East needs their complete medical history — including radiology reports, surgical summaries, lab results, and prescription records — translated from Arabic to English for their new healthcare provider in the United States.

How We Work

1

Send your document

Upload your file or describe the task

2

Get a quote

We estimate cost and timeline within 15 minutes

3

Receive your translation

Completed translation on time with quality guarantee

Our Guarantees

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ISO 9001 & EN 15038

International quality management and translation standard certifications. Every project undergoes 3-stage quality control.

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Confidentiality & NDA

We sign NDA with every translator. Your documents are protected by a non-disclosure agreement.

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Free Revisions

Free revisions within 14 days after delivery. We work until you are fully satisfied.

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Deadline Guarantee

We meet agreed deadlines. If we are late — 10% discount on your next order.

What Our Clients Say

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iTrex translated our clinical trial protocols and patient information leaflets from German into seven target languages for EMA submission. Their medical translators clearly understood pharmaceutical terminology, and the review cycle was minimal compared to agencies we had used before.
Dr. Elena Vorobieva Regulatory Affairs Manager, NovaPharma GmbH
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We coordinate medical treatment for patients traveling from Brazil and Portugal to clinics in Germany and Israel. iTrex translates discharge summaries, lab results, and treatment plans accurately and quickly, which is critical when patients are waiting for follow-up care abroad.
Ricardo Mendes Patient Coordinator, Cross-Border Healthcare Program
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When we acquired a company in Brazil, iTrex translated the full due diligence package — shareholder agreements, financial audits, and regulatory filings — from Portuguese into English and French. Their legal translators caught nuances in Brazilian corporate law that a generalist agency would have missed.
Catherine Dubois Corporate Counsel, Meridian Ventures

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Send your document — we will estimate cost and timeline within 15 minutes

Frequently Asked Questions

What qualifications do your medical translators have?
All medical translators at iTrex hold advanced degrees in medicine, pharmacy, biomedical sciences, or a related life-science discipline, in addition to professional translation credentials. Many are practicing or former healthcare professionals — physicians, pharmacists, clinical researchers — who bring first-hand understanding of medical terminology and regulatory language. Every translator is vetted through a rigorous subject-matter test before joining our medical team.
Can you translate clinical trial documents for regulatory submission?
Yes, clinical trial documentation is one of our primary specializations. We translate investigator brochures, protocols, informed consent forms, CRFs, CSRs, safety narratives, and IND/NDA/MAA submission packages. Our translators are trained in ICH-GCP guidelines and follow CTD (Common Technical Document) formatting standards. We maintain dedicated terminology databases for each therapeutic area to ensure consistency across multi-site, multi-language trials.
How do you handle patient data and HIPAA compliance?
We take patient data protection extremely seriously. All translators working on medical projects sign Business Associate Agreements (BAAs) and undergo HIPAA training. Files containing PHI are transmitted via encrypted channels, processed on HIPAA-compliant infrastructure, and access is restricted to the assigned translation team. We also comply with GDPR for European patient data and can implement custom data handling protocols for additional regulatory frameworks.
Do you translate drug labels and packaging inserts?
Yes, drug labeling is a critical specialty of ours. We translate SmPCs (Summaries of Product Characteristics), PILs (Patient Information Leaflets), outer and inner packaging text, and Instructions for Use (IFUs) for medical devices. Our team ensures that translated labels comply with local regulatory formatting requirements — including character limits, mandatory warning phrases, and Braille compatibility — for authorities such as FDA, EMA, TGA, PMDA, and Health Canada.
What is the turnaround time and cost for medical translation?
Turnaround depends on document type, volume, and regulatory requirements. Standard medical documents (patient records, discharge summaries) are completed in 24-48 hours. Clinical trial packages and regulatory submissions are scheduled based on scope, typically 1-4 weeks for large dossiers. Pricing reflects the specialized expertise required and is quoted per word, with volume discounts for ongoing pharmaceutical partnerships. Contact us with your project details for a free, detailed quote within one hour.

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