USFDA eCTD dossier publishing is a part of KnowledgeNET, is fully compliant with U.S. Module 1 Specification, version 2.01 and version 2.3 and Validation Criteria, version 2.2 and version 3.8 and compatible to generate the STF (Study Tagging File) for module 4 and module 5 in XML format as per STF version 2.6.1.
Our system ready with the updated draft guideline of USFDA Module 1 Specifications version 2.3 and Validation Criteria, version 3.8 implemented from 22 January, 2019.