What is a multilingual regulatory dossier and EMA submission localization?

A multilingual regulatory dossier is a regulatory submission package translated into the languages required by target authorities, while keeping content, terminology and references aligned across modules and annexes. EMA submission localization covers European authority-facing pharmaceutical content, including product information, summaries and supporting documents, in the EU languages required for centralised, decentralised or national procedures. Both are typically managed by regulatory affairs and submission teams. Translation services such as those from AbroadLink combine regulatory-language expertise, terminology control, version management and traceability, while submission strategy stays with the applicant or marketing authorisation holder.