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CoreDossier®: Overview
Overview > Features & Benefits > Technical
Specification
Electronic Regulatory Publishing Made Simple
CoreDossier is a proven, industry-tested software solution that meets all of your regulatory publishing needs.
Backed by an organization with renowned regulatory expertise and a services group that helps
you get the most out of your solution, CoreDossier is the chosen tool for small, mid-size pharma, biotechs, CROs, and global, multi-site organizations
who are all required to create compliant electronic and paper submissions.
When preparing a submission, your success depends on:
- Managing your critical information
- Accessing and compiling source documents
- Reviewing and publishing the dossier
- Complying with continually changing regulatory requirements
In addition to offering improved efficiency of the entire regulatory publishing process and streamlining the reuse of information, CoreDossier
offers users the following features:
- Automates the entire regulatory publishing process
- Transforms over 100 file formats to PDF while maintaining virtually 100% page fidelity
- Integrates with multiple repositories simultaneously
- Implement on one server, or multiple servers depending on need and scalability requirements
- Supports multiple simultaneous output formats (e.g., PDF, paper, CD-ROM, Web, etc.)
- Publishes thousands of submissions, including some of the largest submissions in the world
- Enables fully automated eCTD publishing
- Automates output to meet specific requirements from the FDA
We are aware that during your mission critical submission periods, your organization needs to rely on a tool that can effectively publish your
submission on-time and of a high standard ultimately contributing to your organization’s success. This is why you should depend on the one
company that has proven its ability to deliver solutions that help you:
- Simplify and standardize the entire regulatory publishing process
- Dramatically improve efficiency
- Reduce time to market
- Repurpose your information assets time and again
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