Translation Services

Local-market submissions and labelling require accurate, regulatory-grade translation — and errors here cause rejections, delays and, in labelling, safety risk. General translation is not enough; the work must be done by people who understand the regulatory context and terminology. PharmExpert provides specialist regulatory and technical translation of dossiers, labelling, SmPC/PIL and correspondence.

Regulatory terminology is precise and consequential. A mistranslated dosing instruction or a term that does not match the approved labelling can derail a submission or trigger a field action, so every translation is reviewed for regulatory accuracy, not just linguistic correctness.

We manage terminology and consistency across languages and markets, so a multi-country submission tells one coherent story rather than diverging by translator. This consistency is especially critical for EU labelling across many languages.

We provide certified translations where the market or procedure requires them, and align translated content with the source documents and the QRD templates that govern EU labelling. The result is submission-ready, defensible translations that meet local-language requirements.