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.
US FDA eCTD Software Capabilities
|STF Generation||We support Study Tagging Files (STFs) for module 4 and module 5 for U.S. eCTD|
|US FDA eCTD Template||System have Pre-defined eCTD Template of US region as per regulatory specification|
|eForm Filiation||By using system you can electronically fill the forms required for submission like 356 h form at the time of publishing|
|DMF Submission||KnowledgeNET also DMF publishing software for USFDA|
|Envelop||System automatically generate the Envelop of US as per USFDA Module 1 specification version 2.01 and 2.3|
|Other dossier submission key features click here|