The stakes of medical translation
A mistranslated contraindication, an ambiguous dosage instruction, or an inaccurate patient consent form can directly harm patients. 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 work on legal or technical texts, even if those translators are otherwise excellent.
Regulatory submissions and dossier translation
We work with Spanish and international pharmaceutical companies, CROs and medical device manufacturers on regulatory documentation for AEMPS, 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
- Informed consent forms and patient-reported outcome measures
AEMPS and EMA terminology standards
Regulatory submissions use controlled vocabulary from MedDRA, ICH guidelines, and EMA style guides. Our translators apply preferred terms from official translation memories where they exist. For terms without established Spanish equivalents, we document our translation choices and justifications in a project glossary that accompanies every dossier delivery.