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
  • 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.