eCTD CTD - KnowledgeNET
Dossier life cycle management and publishing solution which create, compile, manage & publish your IND, NDA, ANDA, DMF (Type1, Type2, Type3 and Type4), ASMF and CEP submissions effortlessly,
KnowledgeNET is a complete eCTD dossier publishing & submission solution and is fully compliant with ectd module 1 specifications EU v3.0.3, US FDA (v2.01 and v2.3), GCC v1.2 and v1.5, South Africa (ZA-MCC) v2.1, Canada v2.2, Swissmedic (CH) v1.4, Thailand (Thai-FDA) v1.0, AU v3.1, Jordan v1.0.2 and similar regulatory authorities and NeeS specifications EU v4.0, GCC v1.2 and v1.5, AU v2.0
As Software and service experiance with knowledgeNET we have published more then 2500 dossier for the regions accross the globe