补充描述:
eCTD-PHARMA is software for designing, implementing and electronically submitting medicinal product dossiers according to CTD/eCTD organizational standards, and for managing their subsequent lifecycle, with equally thorough support for Drug Master File active substance dossiers. It functions as a regulatory compliance management system for complex organizations governing a broad portfolio of registration dossiers, oriented around project management of intricate, multi-phase work; project managers can build the dossier's content management structure online and define access and data security plans during implementation, with the workflow supporting coordination of all related activities.
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