What is CTD & what are the document required with CTD in EU and USA registration.
CTD is the acronimus of Common Tecnical Document.
It is the harmonization way to submit the so called Module III, Quality a part of Drug Master File, to the Agencys. It is characterized by several chapters for example 3.2.S.2.2 in which you can fill all the aspects of manufacturing process of your product.
The way to fill and submit is the same for general aspect for USA and EMA.