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
• SOPs
• 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:

- GxP
- 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)

- HIPAA

Click here for details on Marita's background in medical and pharmaceutical translations.