The stakes in medical translation
A mistranslated dosage instruction affects patients. An incorrect adverse event definition in a clinical protocol compromises trial integrity. An imprecise Instructions for Use document for a medical device can cause harm to clinicians or patients. These are not theoretical concerns -- they are the documented consequences of medical translation handled by professionals who understand the vocabulary but not the practice.
Our medical and pharmaceutical translators have worked in clinical settings, pharmaceutical R&D, regulatory affairs departments, or hospital administration. They translate into their native language and hold relevant academic or professional qualifications in their specialist area. We do not assign medical translation to language specialists who have read medical glossaries. We assign it to medical specialists who translate.
For all pharmaceutical and regulatory translations, we apply a mandatory specialist subject review at the editing stage -- a step that is separate from translation and standard proofreading. This creates a three-professional review chain for all high-stakes clinical and regulatory content.
Clinical and medical document types
We handle the full range of pharmaceutical and healthcare documentation:
- Clinical trials: protocols, investigator brochures, study reports, ICFs, CRFs (ICH E6/E3 compliant)
- Regulatory: IND and NDA/BLA dossiers, post-marketing safety reports, FDA correspondence
- Labeling: package inserts, prescribing information, patient information leaflets
- Medical devices: Instructions for Use (IFU), technical files, 510(k) and de novo submissions
- Clinical records: discharge summaries, operative notes, radiology and pathology reports
- Patient materials: informed consent forms, patient education sheets, survey instruments
- Scientific publications: journal articles, conference abstracts, systematic reviews
- HTA: pharmacoeconomic analyses, HEOR models, payer submission dossiers
- Hospital administration: policies, SOPs, accreditation documentation
FDA and regulatory compliance
FDA guidance documents and ICH guidelines have specific requirements for translated submissions. We are familiar with these requirements and produce translations that meet them. For NDA submissions requiring translation, we follow 21 CFR formatting standards and use terminology consistent with FDA-approved labeling.
For patient-facing materials including informed consent forms and patient information leaflets, we conduct an additional readability review to ensure the translated text is appropriate for its intended audience. Back-translation can be arranged as an add-on for documents where this is a regulatory requirement.