What is regulatory submission translation and what does it cover?

Regulatory submission translation is the translation of authority-facing documentation submitted to regulators, notified bodies or agencies as part of approval, certification, maintenance or compliance processes. It typically covers dossiers, modules, annexes, technical documentation, clinical evidence, product information, safety data, labelling and supporting correspondence. The work is performed by qualified medical and regulatory linguists, with controlled terminology, translation memories and consistency with previous submissions. Submission content is then reviewed and finalised by the client according to their internal regulatory, clinical, quality and legal processes for the relevant product and target authority.