eCTD and Electronic Submissions

A specification has been published for the electronic version of the Common Technical Document for pharmaceutical marketing authorisation applications (eCTD) which is built on an XML backbone and uses hypertext links for navigation through the component documents. Various commercial software packages are available for building the dossier.

We have considerable experience in working to the eCTD specification. Many of our recent projects have been provided to clients in "NeeS" format (Non eCTD electronic Submission - i.e. eCTD specification but without the XML backbone). We can also provide submissions for MHRA in "Special Mail 5" format where required.

At present we do not have in-house full eCTD building software and will work with a 3rd party to provide this service if required.

Other types of regulatory submissions can be supplied in pdf format, fully bookmarked and hyperlinked. We are always happy to discuss individual requirements.