Medical & Pharmaceutical Translation

Medical & Pharmaceutical Translation

Clinical documentation, regulatory submissions, medical device files, patient information, and pharmaceutical dossiers.

Medical and pharmaceutical translation is the domain where precision is not a quality attribute — it is the baseline requirement. A patient information leaflet that contains a mistranslated dosage instruction, a clinical trial protocol with imprecise eligibility criteria in the target language, a regulatory submission with inconsistent terminology: these are not quality problems. They are safety and compliance failures.

All medical and pharmaceutical translation at SenseTranslations follows an ISO 17100-compliant workflow: primary translation by a medically qualified specialist, independent review by a second qualified specialist, and QA check before delivery. The translators we use hold degrees in medicine, pharmacy, nursing, life sciences, or medical engineering, with additional language qualifications.

Clinical trial documentation requires particular care for regulatory integrity. We maintain version control and audit trails for all clinical translation projects. Delivery is accompanied by a quality declaration. We have supported AIFA and EMA submission workflows and produce terminology consistent with the relevant authority’s own published guidelines.

For medical device manufacturers, we translate CE marking technical documentation, MDR/IVDR compliance files, instructions for use (IFU), and device labelling. Device labelling is particularly demanding: it must be accurate, unambiguous, and within the space constraints of the physical label.

In practice

A Sicilian pharmaceutical company submitting a product variation to AIFA required translation of 8 regulatory documents from English to Italian. All delivered in 6 business days. The submission was accepted by AIFA without requests for translation revision.
A European medical device manufacturer translating Italian-language instructions for use and technical documentation into English and German for MDR compliance. 14 documents. Delivered in 10 business days. Both translated versions accepted by the notified body.

Questions about this service

Yes. All medical and pharmaceutical translation follows ISO 17100, including independent review by a second qualified specialist.
Yes. We are experienced with both AIFA and EMA submission workflows and use terminology consistent with regulatory authority guidelines.
Medical & Pharmaceutical Translation Medical & Pharmaceutical Translation detail
Starting from
€342.90
4–8 business days · from per project
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What is included
Clinical trial protocols and reports
Regulatory submissions (EMA, AIFA, FDA)
Medical device documentation (CE, MDR)
Patient information leaflets (PILs)
Summary of Product Characteristics (SmPC)
ISO 17100 compliant workflow

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Fixed quote within one business day of receiving your document.

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