Pharmaceutical & Clinical Trial Translation
Clinical study reports, informed consent forms, regulatory submissions for EMA and national agencies, patient materials, and investigator documentation for pharmaceutical and biotech companies.
About this service
Pharmaceutical translation carries a regulatory and patient safety dimension that makes errors unacceptable. An informed consent form that uses the wrong term for a procedure or an adverse event that is misdescribed in a patient information sheet is not a translation quality problem; it is a patient safety problem. Our pharmaceutical translators hold degrees in pharmacy, biochemistry, medicine or related sciences, and have specific experience in regulatory translation to ICH guidelines and EU CTR standards. We translate clinical study protocols and amendments, clinical study reports, investigator brochures, patient information sheets and informed consent forms, summary of product characteristics and package leaflets, pharmacovigilance reports, regulatory submission documents for EMA and ANSM, and scientific publications for peer review. We are familiar with the applicable regulatory terminology in French, German, English, Spanish, Italian, Dutch and Polish and apply terminology consistently across an entire dossier rather than at the individual document level. We work under strict confidentiality and NDA for all pharmaceutical mandates.