eCTD dossier, qos, module 2.4 , 2.5


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?

(HaripriyaMalireddy) #2

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.

(HaripriyaMalireddy) #3

Regulatory department will prepare the eCTD


Thank you so much for the valuable feed back.