How is medical regulatory translation different from general medical translation?

Medical regulatory translation deals with authority-facing content that must reflect approved source documents, regulatory terminology and dossier structure. Unlike general medical translation, it usually has to remain consistent with previous submissions, product information, labelling and clinical evidence over time, sometimes across many country variants. Qualified linguists work with regulated-content expertise, translation memories and terminology references. Workflows are matched to document risk, submission purpose and target authority. Submission timelines and version updates are tracked carefully, with certificates available through CertLink to support QMS evidence and audit readiness.