Submission Management Software
- Manage and publish your composite documents faster
- Stay on top of all Submission formats
- Ensure compliant publications
- Completely web based
- Cloud or on premise
The Submission challenge
The submission of a Marketing Authorization Application (MAA) to the supervising authorities is compulsory for placing a medicinal product on the market. Specifically eCTD, required in both Europe and the US, is complex and needs software to make the process simpler, yet still ensure eCTD-compliant publications.
Ennov Dossier allows you to manage and publish submissions in the most important formats including:
- 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
A technical platform, Ennov Dossier, meets the most demanding requirements for composite files, and is easy to use by users.
Benefits of Ennov Dossier
- Support for CTD, eCTD, Nees, VNees,and eCopy
- Up-to-date versions and submissions
- Reduction of Errors in submissions, avoiding technical refusals by the autorities
- Fully-Customizable by industry experts without programming
- Compliant with FDA, EMA, Canada Health, and 21 CFR Part 11
- Comprehensive technological platform
First of its kind, Ennov8’s new Ennov Dossier Submission and Publication interface is completely web based.
Ennov Dossier is natively integrated with Ennov Doc, our EDMS, thus enabling seamless submissions from document writing to dossier submission.
Manage submissions in multiple formats (eCTD, NeeS, vNeeS, eCOPY…). Ennov Dossier is always up to date with the latest version of these standards.
Better productivity with EDMS
Ennov Dossier, with Ennov Doc, our EDMS, manages submissions as documents while allowing for quick implementation and natively brings many possibilities to your documents and submissions.
Eliminate errors by managing versions, and keep only the most updated version of documents. Allow check-in and check-outs of documents to help collaborate with your teams. Archive and store documents to use for submissions.
You can even create life cycles and automate notifications to relevant recipients.
Easy Publication and Compliance
Quickly and efficiently publish your submissions in eCTD, NeeS, VNeeS, and eCopy.
Manage your eCTD sequences and view your publications in draft mode. An internal validator checks the conformity of your publication with the standards that you have chosen, before or after publication.
Ennov Dossier is compliant and meets the requirements of the FDA, the EMA, Health Canada, particularly the 21 CFR Part 11 (optional) requirements.
- Reduction of errors: in submissions, avoiding technical refusals by the authorities
- Rapid establishment of submissions: even in countries other than origin
- Reduced paper costs, including both circulation and storage
- Diminishing the workload for the IT department, requires no installation on user’s PCs
- Integrated with EDMS
- Supports all common submission formats
- Manage life cycles, especially in eCTD
- View publications in draft mode
- Integrated validator
- Manage storage and archiving
- Manage eCTD sequences
- Intuitive search engine
- Validates hyperlinks
- Scalable software
- 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 compliant product catalog
Comprehensive regulatory information management solution
Why Choose Ennov ?
Hundreds of corporate customers trust Ennov Dossier
- 15 Years of experience in EDMS
- 150+ life science customers, many more in other industries
- Modern architecture and interface
- Application server for scalability
- Entirely web based interface
- You matter to us
- 98.5% of projects delivered on time and within budgets
- High and improving customer satisfaction
We respect your freedom of choice
- Available as cloud or on premise.
- You can switch between options at any time.
- We make you autonomous
- Configuration requires no IT skills
- Integration through REST API
- Improved security and optimized performance.
- If cloud based we offer single-tenancy to minimize version upgrade risks and validation upgrades.
- 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.
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+1 (919) 924 5004
Paris – Headquarters
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75010 Paris – France
+33 (0) 188.8.131.52.38
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Chuo-ku, Tokyo 104-0045, Japon