eCTD DOSSIER

WHAT IS eCTD WRITING?

By eCTD writing we mean the writing of 

the content of the dossier, 

from module 1 documents (product information, RMP etc) and module 2 summaries and overviews, 

to all the different module 3 documents 

and the study reports etc in modules 4 and 5.  


We combine knowledge in writing and science to produce fit for submission documents in compliance with current guidelines, templates, and standards.

eCTD PUBLISHING

The RegFile team will support you in the document preparation and publishing to a fit-for-submission eCTD sequence.