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FDA Mandat
The Common Technical Document (CTD) is the compulsory format of submission dossiers for Japan, the US and the EU since July 2003. Australia, Canada and Switzerland are about to join this standard.
For the facilitation of submission procedures, the authorities discuss the implementation of the electronic submission. The e-CTD follows the structure of the CTD, but is based on PDFs and includes all pertinent documents as digital files. What will change when the e-CTD comes?
All documents must be submitted both electronically and in hardcopies.
A coexistence of paperbased dossiers and their digital correspondent will be the case for many years.
The impact on printing is significant: You will not have to care about photocopying a multitude of different pages. You will prepare the e-CTD based on embedded XML directories and PDFs and then transfer the whole dossier to PharmaForms. We will print it for you. Quick, reliable, quality assured.
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