Medical & Pharmaceutical Translations
Based on our specific training and/or translation experience, we offer translations in the following medical and pharmaceutical areas:
- Clinical trial agreements and other contracts
- Informed Consent Forms (ICF)
- Patient Information Leaflets (PIL)
- Summaries of Product Characteristics (SmPC)
- Doctor and patient guides
- Patient diaries
- Patient questionnaires and surveys
- Codes of ethics and anti-corruption policies
- Medical software
- Healthcare IT
- Regulatory affairs: translations related to medical device and pharmaceutical regulations and standards (e. g. online training courses for medical personnel), including but not limited to:
- EU directives
- FDA regulations, e. g. 21 CFR Parts 11, 50, 56, 312, 820; CAPA etc.
- FDA documents: 510(k), Form 483, Warning Letters, FDA QSRs, FDA inspections
- ISO and other standards, e. g. ISO 13485, ISO 9001 etc.
- Medical Device Regulation (MDR)
Click here for details on Marita's background in medical and pharmaceutical translations.