PharmInvent’s Complete Regulatory Dossier Management and Assembly Service
May 25, 2017
PharmInvent is pleased to announce that we now hold a complete regulatory dossier management and assembly tool. This tool ensures full compliance with ICH and regional specifications, as well as electronic submission gateways. We have purchased a license for eCTDmanager, an eCTD management software solution from EXTEDO GmbH. Using this single application, we can now make it easier for our clients to build, view, publish and validate submissions based on standardised submission formats (eCTD, NeeS, Paper). Our new software includes a built-in validator used by more than 35 regulatory authorities worldwide. EXTEDO eCTDmanager further enables us to create and manage hyperlinks and thus turn the collection of documents into a dossier where the information is linked. Pre-existing eCTD sequences, if already created by our clients, can be easily imported into the system.
To learn more about making use of this new service, please contact us.