Submission Management Software
- Create and manage your Regulatory dossiers
- Publish to any output format
- Ensure compliant submissions
- Robust hyperlinking and bookmarking
- 100% web-based, in the cloud or on premises
The Submission challenge
The efficient production of compliant regulatory submissions is the goal of every regulatory operation. Having a single publishing solution that can effectively produce a variety of submission output formats provides a distinct advantage in terms of flexibility, training and total cost of ownership.
Ennov Dossier is a complete and scalable dossier management and submission publishing solution that is suitable for regulatory operations of all sizes. Ennov Dossier produces output that is compliant with all current health authority requirements:
- CTD (Common Technical Document) for paper publications
- eCTD and NeeS (Non eCTD electronic submission) for electronic publications
- vNeeS for the veterinary sector
- eCopy for medical devices
Ennov Dossier is comprehensive and meets the most demanding requirements for regulatory submissions while still being intuitive and easy to use.
Benefits of Ennov Dossier
- Support for CTD, eCTD, Nees, VNees,and eCopy formats
- Regional eCTD templates for FDA, EMA, Health Canada, Swissmedic, TGA and GCC
- Easy-to-use submission assembly controls for the capture and management of eCTD metadata
- Drag & drop documents from Ennov Doc or any WebDAV repository into the submission assembly
- Robust hyperlinking, bookmarking and eCTD validation functionality
- 100% web-based, ideal for multi-site or global deployments
Efficient and easy to use
Ennov Dossier provides the ability to build, manage, publish, validate and archive regulatory dossiers using the native capabilities found within Ennov Doc.
This eliminates the fragmented and inefficient processes of locating, copying and uploading the documents that you need for your regulatory submissions – providing a harmonized and seamless dossier publishing solution.
A simple drag-and-drop interface allows publishers to link documents into submission assemblies quickly and easily.
Better productivity with EDMS
Ennov Dossier, when combined with Ennov Doc, provides the ability to manage your regulatory dossiers using all of the robust functionality of our innovative EDMS.
Automated dossier life cycles, workflows and notifications eliminate fragmented manual processes and increase productivity.
Ennov’s unique metadata-based navigation also helps improve productivity by allowing users to quickly locate dossiers using their properties rather than a storage location in a filing hierarchy.
Easy and compliant submission publishing
Submission assembly templates are provided for the regions that accept eCTD submissions (e.g. US, EU, GCC, Canada, Swissmedic, TGA) as well as for other non-eCTD formats and can be modified to meet a client’s specific requirements. Ennov provides regular updates to these templates as the regulatory guidance changes.
Ennov Dossier also provides the ability to create Tables of Contents, hyperlinks, bookmarks and other navigation aides to assist in the review of the dossier.
During publishing all the necessary components for a compliant submission, including the required ICH and regional XML files, correctly named leaf files and folder structures are created.
- Ease of use: intuitive user interface results in high adoption rates
- Comprehensive capabilities: publish to any output format, for any market
- Rapid creation of submissions: using supplied assembly templates
- Eliminate errors: built in eCTD validator reduces Refusal to File risk
- Reduced IT workload: 100% web-based, requires no desktop installation
- Integrated with Ennov Doc EDMS
- Supports all common submission formats
- Manages dossier life cycles
- View publications in draft mode
- Integrated eCTD validator
- Manages storage and archiving
- Manages eCTD sequences
- Intuitive search engine
- Robust hyperlinking and bookmarking
- 100% web-based interface
Cloud-based or On Site
Ennov Dossier in our content management solution.
Regulatory document management, DIA EDM reference model
eCTD, NeeS, vNeeS, CTD submission dossier management
IDMP ready products and services
Comprehensive regulatory information management solution
Why Choose Ennov ?
Hundreds of corporate customers trust Ennov Dossier
- Over 15 Years of experience providing electronic document management solutions
- 150+ life science customers, many more in other industries
- Modern architecture and interface
- Highly scalable application server
- 100% web-based and user-centric design
- You matter to us
- 98.5% of projects are delivered on time and within budgets
- Very high levels of customer satisfaction
We respect your freedom of choice
- Available for cloud-based or on-premises deployment.
- You can switch between options at any time.
- We make you autonomous
- Configuration and management require no IT skills
- Integration through REST API
- Improved security and optimized performance.
- If cloud-based deployment is selected, we offer single-tenancy to minimize business interruption
- Data is hosted locally for total flexibility
Structuring AND intuitive
… eCTD properties …
… create hyperlinks
To book a demo, the best way is to fill the following form. You will be contacted very quickly by our team.
Send us a mail at: firstname.lastname@example.org.
Contact our European office.
San Jose, USA
75 E Santa Clara St – WeWork
San Jose, CA 95113
+1 (833) 366-6887
Paris – Headquarters
251 rue du Faubourg Saint Martin
75010 Paris – France
+33 (0) 126.96.36.199.38
5 Eaton Court Road, Colmworth Business Park
Eaton Socon St Neots Cambridgeshire PE19 8ER – UK
+1 (919) 924 5004
Tsukiji N°1, Nagaoka Building 2-3-4 Tsukiji,
Chuo-ku, Tokyo 104-0045, Japon