Thai FDA (Thailand) plan to accept dossier in eCTD format: The Drug Regulatory Authority of Thailand (Thai FDA) has initiated the acceptance of Pilot eCTD from October 2014.

Authority has scheduled to receive the eCTD submission from May 2015.

KnowledgeNET is unique software, which is fully compliant with Thai-FDA Module 1 Specification, version 1.0 and Validation Criteria version 1.0, will be required by Drug Regulatory Authority of Thailand (Thai FDA) has initiated the acceptance of eCTD from May, 2015.

Thai-FDA eCTD Software Capabilities

Thai-FDA eCTD Template System have Pre-defined eCTD Template of Thailand (Thai-FDA) region as per regulatory specification
Project Management In one project, system can manage all related sequences from sequence 0000 to infinity
Tracking Table Generation System generate Tracking Table
Envelop Generation System automatically generate the Envelop of Thailand as per Module 1 specification version 1.0
Documents Transformation Transformation of source documents (MS Word) to pdf format through the system at time of publishing
Other dossier submission key features click here