Benjamin Fermantel

For pharmaceutical laboratories, CROs, and medical device manufacturers, access to the French-speaking market represents a major opportunity, but also a significant regulatory challenge, as the requirements of the EMA and ANSM leave no room for approximation.

As a native medical translator, I assist English-speaking companies in the rigorous transposition of their scientific, clinical, and regulatory documents into impeccable French, whether for content intended for professionals or the general public.

- Regulatory affairs: Translation of your marketing authorization applications (MAA), Summary of Product Characteristics (SmPC), package leaflets, and labeling, with strict integration of the latest QRD templates and EDQM standards.

- Clinical trials: Translation of study protocols, investigator brochures, and informed consent forms. I ensure that information is communicated to French-speaking patients using accessible and legally protective language.

- Medical devices: Translation of your user manuals, operator manuals, and software interfaces for surgical or diagnostic equipment, guaranteeing safe use by healthcare personnel.

- Sense of nuance: English uses many acronyms and neologisms that cannot be translated literally. I master the exact equivalents validated by the MeSH thesaurus and the MedDRA dictionary.

- Reduced time-to-market: A poorly translated document leads to back-and-forth exchanges that delay your product launch. I provide you with "ready-to-use" deliverables.

- Responsiveness: Accustomed to working with international teams, I adapt to your workflows and your strictest confidentiality requirements (confidentiality agreements, HIPAA/GDPR compliance).