Medical & Pharma Translations

 

Based on our specific training and/or translation experience, we offer translations in the following medical and pharmaceutical areas:

 

• patient questionnaires, surveys and outreach materials
• informed consent documents
• clinical study and other contracts

• patient information leaflets (PIL)
• summaries of product characteristics (SmPC)

• codes of ethics and anti-corruption policies

• medical software
• healthcare IT

 

• regulatory affairs: translations related to medical device and drug regulations and standards (e. g. online training courses for medical personnel), including but not limited to:
- Medical Device Regulation (MDR) 
- 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.
- HIPAA

 

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