Clinical trial protocols, FDA regulatory submissions, medical device documentation, patient records, and pharmaceutical labeling. Translated by specialists with life sciences backgrounds.
3-5 business days for standard documents. Complex regulatory submissions quoted individually.
Medical translation errors have real consequences. A mistranslated dosage instruction in a patient information leaflet, an incorrect contraindication statement in a labeling document, or a terminology error in a clinical trial protocol can create serious outcomes. This is why we do not assign medical translation projects to general translators, regardless of their language fluency.
Every medical translation at Translators Worldwide is handled by a translator with a documented background in life sciences, medicine, pharmacy, or a related regulated field. We require translators to provide evidence of subject-matter expertise before they are approved for medical project work.
Translations submitted as part of an FDA regulatory dossier must meet specific accuracy standards. Device manufacturers applying for 510(k) clearance, pharmaceutical companies submitting NDAs or ANDAs, and clinical trial sponsors submitting IND applications all need translations that hold up under FDA review. We work with the regulatory teams at our clients to understand the submission context before starting translation, not after delivery.
We translate FDA submission documents including clinical study reports, investigator brochures, informed consent forms, device labeling (Instructions for Use, Quick Reference Guides), and CDER and CBER regulatory correspondence.
Instructions for Use documents for medical devices sold in international markets must meet the requirements of the target market. For EU MDR 2017/745 compliance, IFU documents must be translated into the official language of every EU member state where the device is marketed. We handle multi-language IFU projects with a single project coordinator managing all language pairs, ensuring terminology consistency across the full language set.
Patient information leaflets, informed consent forms, and patient-reported outcome questionnaires require a different approach than regulatory submissions. These documents need to read clearly and naturally in the target language, not just accurately. We use translators who understand the target patient population and write at the appropriate reading level for the target market.
Our medical translators have life sciences backgrounds, typically degrees in medicine, pharmacy, biochemistry, nursing, or a related field. Not all hold clinical qualifications, but all have verifiable subject-matter expertise. We match translator background to the specific document type.
Yes. We regularly handle FDA submissions requiring 10-20 language pairs. A single project coordinator manages the full scope, and a shared terminology glossary ensures consistency across all languages.
Yes. All medical and pharmaceutical project files are treated as strictly confidential. NDAs are included as standard on all medical projects. Files are not shared with any third party beyond the assigned translator and proofreader.