US FDA eCTD
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