Can AI be used for regulatory submission translation?

AI can support regulatory submission translation only as a controlled pre-translation step, not as a replacement for qualified human review. Through aiHubLink, AbroadLink can use client terminology and previous submissions to generate an initial draft, which is then fully reviewed and validated by qualified medical and regulatory linguists within ISO-based workflows. For multilingual regulatory dossiers, EMA submission content, medical regulatory translation, authority-facing documentation, clinical evidence, product information, safety information, labelling, technical documentation and pharmaceutical dossiers, AI is positioned only as a controlled support option, with traceability through CertLink where appropriate.