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Preparing a Briefing Book (or Briefing Document) for interactions with regulatory agencies demands thorough attention to detail and a keen understanding of the information provided. This type of document often requires, depending on the issues, input from different functions (CMC, preclinical, clinical, regulatory, …).
Emtex Statisticians enhance the quality of briefing packages by incorporating pertinent design- and analysis-related inquiries and any other important contributions depending on the needs of the situation. By leveraging their expertise, Medical Writers ensure that briefing materials effectively communicate the scientific rigor and integrity of the information, facilitating a smoother regulatory interaction process.