Medical Translation Services
Specialized translation of pharmaceutical documentation, clinical trial protocols, patient records, and drug labels by linguists with medical and life-science backgrounds.
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
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.
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.
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.
Try Before You Pay
Request a free trial translation — up to 1 page. Evaluate our quality with no obligation.
When You Need This
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.
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.
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.
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
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Upload your file or describe the task
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Completed translation on time with quality guarantee
Our Guarantees
ISO 9001 & EN 15038
International quality management and translation standard certifications. Every project undergoes 3-stage quality control.
Confidentiality & NDA
We sign NDA with every translator. Your documents are protected by a non-disclosure agreement.
Free Revisions
Free revisions within 14 days after delivery. We work until you are fully satisfied.
Deadline Guarantee
We meet agreed deadlines. If we are late — 10% discount on your next order.
What Our Clients Say
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.
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.
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.
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Frequently Asked Questions
What qualifications do your medical translators have?
Can you translate clinical trial documents for regulatory submission?
How do you handle patient data and HIPAA compliance?
Do you translate drug labels and packaging inserts?
What is the turnaround time and cost for medical translation?
Get a Free Quote
Send your document — we will estimate cost and timeline within 15 minutes