Module 4 and Module 5 are a part of common technical document and contain the results of animal studies and human clinical trials with the investigational product. The appropriate format for the organization and contents of both modules are fully described in ICH guidelines. Because these models are intended for regulatory authorities, the strict adherence to the guidelines is necessary and the ease of the evaluation is the hallmark of their quality.

Biomapas can prepare for you a full eCTD-compliant dossier or certain parts of the dossier such as Modules 4 and 5, Non-clinical and Clinical Overviews and Summaries, Quality Overall Summary etc. Our Medical writers have the expertise and experience in preparing cohesive, scientifically and technically sound documents that facilitate their evaluation by the regulatory authorities.