Medical writing at Winicker Norimed
Our team of experienced medical writers has profound experience in the preparation of scientific information material. Through close cooperation among our specialist departments, we achieve the highest quality of services.
In addition to meticulous planning and management, accurately written study protocols or observational plans and coherent study reports are vital for successful study conduct and project completion.
For clinical and non-interventional studies as well as CTD modules, the ICH guidelines (e.g. ICH-E3, ICH-E6 and ICH-M4) and, where applicable, the PASS recommendations by the EMA, are the foundation of our work. In the medical devices sector, we also work in accordance with ISO14155 and MEDDEV.
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+49 (0) 911 / 92680 – 8736