Case studies
As a professional translator, I’ve had the privilege of helping many clients in the healthcare sector expand to the French-speaking market and consistently received positive feedback for providing high quality medical and pharmaceutical translations.
In this series, I present case studies of recent translation projects, offering a glimpse into the strategies, challenges, and successes that make each translation unique.
Drug product information for the Swiss market
In more than a decade working as a freelance pharmaceutical translator, I have translated a huge number of drug product information into their patient-friendly version or more comprehensive and technical version for healthcare professionals.
Translating these documents, which are reviewed and approved by the Swiss national authority, requires absolute accuracy and a deep understanding of drug pharmacology, efficacy or safety. While translating these documents, I always keep in mind how crucial accurate information is to enable healthcare professionals to make informed decisions about the most appropriate treatment and for patients to understand their medication.
At a glance
Client profile: Pharmaceutical companies wishing to market human drugs on the Swiss market or linguistic service providers.
Objectives:
- Translate information for healthcare professionals and patient information
- From German to Swiss French
- To submit marketing authorization applications
- Or to implement changes after authorization
Challenges:
- Implementing all national requirements of pharmaceutical translations.
- Crafting a ready-to-submit information within a tight deadline.
- Ensuring coherency within the document and with previous document versions/similar human drug product.
Process:
- Translation from scratch or implementation of changes to the product’s information and/or review of the initial translation.
- Implementation of quality assurance processes to ensure compliance with regulatory standards like templates, MedDRA and EDQM terminology, as well as national requirements.
- Quality checks to ensure high linguistic standards and precision of translation.
Benefits:
Regulatory compliance
- Ready to submit information materials in French.
- Efficient and compliant regulatory submission within the time limits of the authority.
… and additional support
- Pointing out inconsistencies or mistakes in product information to help reduce the back and forth with the authorities.
