Protocol-driven reviews that convert mixed-quality literatures into decision-ready briefs. Searches and selection steps are documented (PRISMA/PRISMA-S); study quality is profiled with RoB 2 and ROBINS-I; confidence is graded with GRADE where appropriate. Figures make effect direction and magnitude plain, and archived strategies with a managed citation library support audit and reuse. Options and trade-offs are stated clearly for leadership decisions.
Regulatory Communication
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.
Medical Writing
Publication-grade, submission-ready documents for journals and regulators, written in a single voice across manuscripts, protocols and SAP text, Clinical Study Reports, and structured summaries. Standards are built in, CONSORT, PRISMA, ICMJE, ICH, so methods are transparent, claims are calibrated to evidence, and every number traces to source. Delivery is predictable: a dated draft with tracked changes and a concise comment log, followed by a focused revision that closes open questions.