Benefit from a fully integrated electronic process and a completely managed platform.
eCTD 247 is a cloud-based fully integrated electronic submissions and document management solution.
With eCTD 247, the eCTD knowhow is embedded into the software itself in a simplified intuitive manner, thus saving you time, money and resources.
Simplified Regulatory Submissions
Prepare, manage and submit your IND, NDA, ANDA or BLA submissions, regardless your level of eCTD expertise. With the eCTD 247 Essential package, simple eCTD submissions can be published by yourself. For more complex submissions, you can get help by using our submission services.
Compiling an eCTD submission is just the final step. The key is to have all documents ready on time and accessible. eCTD 247 is a cloud platform that helps you securely manage your regulatory content.
The included document management system (EDMS) enables fast document access through the search engine or by navigation in configurable views. It also manages templates so that users can effortlessly create documents that comply with internal document guidelines. The reporting capabilities also enable to cut audit preparation time.
Original applications, supplements, variations, amendments are fast to build, update and submit thanks to hyperlink and bookmark management, automatic build and edit of Study Tagging Files (STFs), fast access to eCTD status, and drag and drop based dossier construction.
Lower compliance Risk
Compliance with 21 CFR Part 11 is facilitated by the native traceability and electronic signature included in eCTD247. eCTD standard compliance can be checked with the integrated eCTD validator. For submissions to European Regulatory Authorities, this validator has also approved by the EMA.
We support all the main existing human & veterinary submission formats, current and older versions (eCTD, NeeS, vNeeS, paper CTD).
Increase submission quality and consistency
eCTD247’s included document management system (EDMS) manages document validation so that all documents follow the pre-defined validation process.
Documents tracked with version control: the EDMS manages document versioning, and documents inserted in dossiers can be automatically refreshed to automatically mirror the latest available document version.
Increased process transparency and visibility
The release of documents is managed so that relevant people are always informed. Authors are also informed when receivers have opened the released documents. Documents can also be reviewed and commented on simultaneously.
Documents and dossiers access rights are also managed so that open or private and public working groups can be created.
Improved workforce productivity
Ennov supports parallel work locally and worldwide, providing a full web interface, and managing document check-in / check-out.
48% cost reduction
Infrastructure costs are eliminated (taken care of by Ennov) and required internal IT personnel and services reduced to a minimum. Hosted software updates can occur without requiring work on the sponsor’s part. Validation activities can also be managed as a part of the cloud offering.
You can login from anywhere in the world and work efficiently with access to all your data. This also provides the ability to grant access to external consultants or partners as needed.
Choose your location
Ennov hosts your data in the United States or in France, according your choice. In both cases, your data and your application are on a highly secure server, and one or more virtual machines are dedicated to you. We store data and ensure a quick recovery in case of disaster.
Always be up to date with submission compliance
Updates are performed regularly by Ennov, to improve the software and more importantly to follow the evolution of regulatory standards and regulatory norms. eCTD247 supports current as well as former versions of eCTD, NeeS, vNeeS…