Medical Translation Services for Regulated Content

We have turned away medical projects where we lacked a qualified specialist. When a clinical study report on a rare oncology drug arrives, we check our network before we confirm. If we cannot find a linguist with documented oncology experience in that language pair, we say so. The consequence of getting it wrong is concrete: the Joint Commission attributes around 70% of sentinel patient-safety events to communication failures, including moments where real-time telephone interpreting is the safer choice for urgent patient communication. A missing warning on a device IFU or an incorrect dosage on a pharmaceutical insert sits squarely inside that risk. Every medical project we accept goes to a linguist with clinical or scientific training, reviewed by a second specialist, and validated against the terminology hierarchy of the regulator the document is destined for.

We work with pharmaceutical firms, hospitals, clinics, medical device manufacturers, contract research organizations (CROs), and academic research institutions across 100+ languages. Regulatory pipelines we handle daily: FDA submissions (IND, NDA, ANDA, 510(k), De Novo, PMA), EMA centralized and decentralized procedures, MHRA filings post-Brexit, Health Canada submissions, TGA dossiers for Australia, PMDA filings for Japan, and ANVISA submissions for Brazil. EU MDR Regulation 2017/745 mandates Instructions for Use in every official language of every member state where the device is marketed; we deliver compliant translations across all 24 EU official languages plus Norwegian, Icelandic, and Swiss German for EFTA/EEA distribution. Clinical trial documentation, device technical files, and patient records needing certified translation are produced to ICH-GCP standards, with manufacturing-related content aligned to GMP. Our QA process is aligned with ISO 17100 and ISO 13485 medical-device quality management requirements.