Documents to be submitted to national authorities for regulatory purposes must be translated, as well as technical, regulatory, clinical or marketing documentation for pharmaceutical, medical or surgical devices. Clinical trials that are carried out to assess the safety and efficacy of investigational drugs and devices are usually funded by pharmaceutical companies, their procedures and agreements require translation to obtain authorization by national regulatory authorities.
Medical texts can range in register from non-technical to highly technical, therefore medical translation requires linguistic skills and specific training, as well as knowledge of the subject matter.
Human Medicine:
- New Drug Application (NDA) procedures
- Marketing Authorization Application (MAA) procedures
- Clinical protocols and clinical protocol synopses
- Informed Consent Forms (ICF)
- User Interface (UI) for Medical Devices
- Localization of medical software
- Clinical testing procedures
- Medical Imaging
- Case Report Forms (CRF)
- Patient Information Leaflets (PIL)
- Clinical Study Agreements and contracts
- Physician manuals
- Instructions for Use (IFU) for medical devices
- User Manuals for medical devices
- User Guides for medical software
- Pharmacovigilance reports
- Surgical procedures
- Surgical device
- Clinical trials agreements
Veterinary Medicine:
- Animal health
- Veterinary drugs
- Veterinary equipment
- Veterinary procedures