Bioequivalence and Bioavailability Forum

Dear Mr Kumar,

❝ I want to learn the procedure of CTD and eCTD for Module 5.

Go through the following links and Presentations to learn the procedure of CTD and eCTD for Module 5.
FDA's eCTD Guidance and Specifications
FDA's Electronic Submissions Presentations

❝ Which type of tools can be used to prepare e-CTD document for FDA submissions.

FDA as a government agency does not recommend specific software or tools. Information on tools, vendors, and eCTD preparation firms may be obtained by Internet search. FDA recommends to choose eCTD software and tools that allow you to build, validate, and view an eCTD.

Some eCTD tools which are available in the market (to name some) are
ALicE 4eCTD, AspireeCTD, DocuBridge, DoubleBridge, eCTD consultancy, eCTD indexer, eCTD Office, eCTD Software, Educesolutions, Exalon, Extedo, Global submit, IBM Score, Imagesolutions - eCTDXpress, Infotehna , IRISS, KnowledgeNet, Liquent, Lorenz, Mastercontrol, Medxview, Octagonresearch, P2 eCTD, Pharmaready, Quark, ROSETTA, SamarindRMS etc.,