The stakes of medical translation
A misplaced decimal in a drug dosage instruction, a mistranslated contraindication, or an ambiguous consent form can directly harm patients. This is not an industry where approximate translation is acceptable. Every document produced by our medical translation team is handled by a translator with formal training in pharmacology, medicine, biochemistry, or a related healthcare discipline.
We do not assign pharmaceutical regulatory submissions to translators who usually handle legal or technical texts, even if those translators are otherwise excellent. The specialisation requirement is absolute.
Regulatory submissions and dossier translation
We work with Italian and international pharmaceutical companies, CROs, and medical device manufacturers on regulatory documentation for submission to AIFA, EMA, and national competent authorities across Europe.
- Summary of Product Characteristics (SmPC) and package leaflets
- Clinical study reports and clinical trial protocols
- Investigational Medicinal Product Dossiers (IMPD)
- Risk management plans and pharmacovigilance documentation
- Medical device technical files under EU MDR 2017/745
- IFU (instructions for use) for in vitro diagnostic devices
- Informed consent forms and patient-reported outcome measures
ICH and EMA terminology standards
Regulatory submissions use controlled vocabulary from MedDRA, the ICH guidelines, and EMA style guides. Our translators work within these frameworks and apply preferred terms from official translation memories where they exist. For terms without established equivalents in the target language, we document our translation choices and justifications in a project glossary that accompanies every dossier delivery.
Patient-facing and clinical communications
Package leaflets, informed consent forms, and patient recruitment materials require a different register from regulatory dossiers: clear, readable language that a patient can actually understand, while remaining medically accurate. Our team produces both types: the regulatory submission version and the patient-friendly version. If you need both, we can deliver them from the same project.