What is eCTD, Dossier, module 2.4, module 2.5 and who prepares it and how long it will take to prepare these and if I go for any BPO or KPO how much they will charge on each document?
eCTD is the electronic form of technical document containing administrative information (M1), chemistry, manufacturing, controls of drug substance and drug product (M3) and clinical trails data (M4&5) and is submitted to regulatory body for the marketing approval.
Module 2 is called as Quality overall summary. It contains a question based information of physical and chemical properties of drug, it’s characterization, manufacturing process and controls, reference and impurity standards, characterization, stability study data, sterility assurance controls briefly.
Regulatory department will prepare the eCTD
Thank you so much for the valuable feed back.