- Consultancy
Strategy and procedures
- Services
- Solutions
Dossplorer regulatory dossier viewer
Submission document templates and content plan
- Customers & Cases
Hosted electronic submission management
platform
Ready to use in-house platform
Qdossier offers hosted electronic submissions and services using our in-house publishing platform. We use this platform ourselves for the preparation of eCTD, non-eCTD electronic submissions and other dossier formats, but our customers can also view and/or review these through Dossplorer™.
Global publishing and validation
In-house, Qdossier uses two of the major eCTD software tools, namely Lorenz Docubridge® and Extedo eCTDmanager™.
We can compile, validate, host and maintain eCTDs, non-eCTD electronic submissions, NeeS and ASEAN-CTDs for all countries worldwide, for all companies worldwide on our in-house publishing platform for hosted electronic submissions and services.
Dossplorer regulatory dossier viewer
Once published, customers can access their dossiers via Dossplorer™. Dossplorer™ allows you to share, compare, view and review eCTD, NeeS and other dossier formats from any region. The hybrid cloud/ on premise solution offers cloud-based software as a service whilst keeping your data privately stored on premise (either at your company or at Qdossier’s in-house publishing platform for hosted electronic submissions and services). We can fulfill the role of dossier- and business administrators for your company and take care of the recordings of your dossiers in Dossplorer™ and manage the user administration.
Qdossier provides all services required for succesfull submission management: efficient publishing of regulatory documents to submission readiness according to standardized procedures and workflows, including quality checks
Dossplorer™ allows you to share, view and review eCTD, NeeS and other dossier formats from any region and access them from any location. Unlock and explore the true value of your regulatory dossiers.
Support for both emerging and established pharmaceutical companies in defining and executing regulatory strategic activities.