Save time identifying dossiers of interest, by easily searching on metadata
Get a centralized overview of regional submissions compiled by local affiliates
Simultaneously collaborate using in-progress submission access
Are you still using your publishing tool to review submission content?
Without a dedicated tool to check submission content, reviewing submissions becomes a complex and cumbersome process.
- I am not able to quickly identify what has changed within the lifecycle of a submission
- I am overwhelmed by the number of tools I have to use to review submissions
- I struggle meeting the regulator’s procedural timelines during the assessment period
- Using our publishing to check submission content is complex and cumbersome
- I can’t easily collaborate and share comments with other reviewers
- I struggle to have transparency of what our external publishers are working on
- We struggle to work with submissions that don’t follow the established format
- Viewing and reviewing submissions using new or outdated formats is a challenge
Viewing, reviewing and comparing submissions should be effortless.
Simply review the entire structure of submissions in a centralized place, using your regular web browser.
Single source of truth
eSUBmanager provides an overview of all folders, documents, and metadata that form submissions and applications.
Use document placeholders to insert planned content into the submission structure before it is authored.
Built with simplicity at its heart eSUBmanager reduces complexity and let’s you focus on what’s most important – high-quality dossiers.
Your plan to effortless compliance
Schedule a call
Choose a time to meet. We’ll discuss your goals and uncover your challenges with reviewing submissions.
Get a free consultation
Our experienced business and technical team will outline a solution to solve your challenges.
Review submission with ease
With a dedicated reviewing tool you can easily view and comment on all submissions throughout your organization.
Streamline your submission reviews
Submission reviewers are overwhelmed by the complexity of dedicated publishing tools. eSUBmanager streamlines the viewing, reviewing and comparison of regulatory submissions, reducing costs by minimizing time spent reviewing and eliminating friction between teams.
Request your personal EXTEDO Software Demo now!
Some of our Customers
Tailored specifically to the needs of regulatory and related stakeholders, EXTEDO’s business process and regulatory consulting services are designed to support you during and after your eCTD submissions. Through a series of workshops, our team of experienced consultants will establish your business needs, understand your processes, and help you to define the most appropriate implementation approach.
Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.