Medical & Pharmaceutical Translation

Medical & Pharmaceutical Translation

Clinical documents, regulatory submissions, medical devices, and pharmaceutical dossiers with medically qualified translators.

Medical translation is the domain where the cost of error is not measured in revision cycles. Regulatory submissions, clinical trial documentation, and patient-facing materials require medical accuracy that can only come from translators with medical or pharmaceutical training. We do not translate medical content with language generalists.

Our medical translators hold degrees in medicine, pharmacy, life sciences, or medical engineering, with additional language qualifications and professional translation experience. All medical translation follows an ISO 17100-compliant workflow: translation, independent medical review, QA check.

Regulatory submissions are a particular area of expertise. We have supported Italian pharmaceutical companies with AIFA submissions, European companies with EMA submissions requiring Italian text, and medical device manufacturers with CE marking technical documentation. Regulatory terminology is consistent with the relevant authority's own published guidelines.

For clinical trial documents, we maintain strict version control and audit trails. Every document version is tracked, every change is recorded, and delivery is accompanied by a quality declaration. This is a baseline requirement for GCP-compliant clinical translation, not an optional extra.

In practice

A Genova biotech company submitting a Phase II clinical trial application to AIFA required translation of the full clinical study protocol, investigator brochure, and patient information/consent documentation from English into Italian. 186 pages total delivered in 8 business days. AIFA accepted the submission without requests for translation revision.
A European medical device manufacturer entering the Italian market needed CE marking technical documentation translated into Italian for IVDR compliance. 24 technical documents, 840 pages. Delivered over 10 weeks.

Questions about this service

Yes. All medical and pharmaceutical translation follows an ISO 17100-compliant workflow with translation, independent review, and QA before delivery.
Yes. We have experience with both EMA and AIFA submission workflows and use regulatory-consistent terminology.
Medical & Pharmaceutical Translation Medical & Pharmaceutical Translation detail
Starting from
€389.40
3–6 business days · from per project
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What is included
Clinical trial protocols and reports
Regulatory submissions (EMA, FDA, AIFA)
Informed consent forms
Medical device documentation (CE marking)
Summary of Product Characteristics (SmPC)
ISO 17100 compliant workflow

Medical & Pharmaceutical Translation.
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