Clear, consistent dossiers and briefing materials for EMA, FDA, MHRA, and Swissmedic, structured to map cleanly to eCTD modules. Clinical and non-clinical summaries align with ICH E3/E6/E9; briefing books and point-by-point responses are prepared for rapid verification. Labeling follows EU SmPC/PL with QRD conventions and U.S. PLR formatting, with regional variants tracked. Device submissions are supported across 510(k), De Novo, and PMA routes without overstated certainty.