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Overview > Features & Benefits > Technical Specification

EZsubs® offers a full range of publishing capabilities seamlessly integrated into the Documentum® user interface. These capabilities enable you to meet your regulatory publishing needs thus helping you achieve quality, accuracy, and data integrity to deliver regulatory reports and submissions reliably and on time. It is an industry proven solution, suitable for all sizes of pharmaceutical, biotech and CRO organizations that are required to create compliant electronic and paper submissions.

Whether you are in the early stages of drug development or submitting a full scale dossier, EZsubs provides the ability to accelerate each stage of your product development lifecycle. It also provides a fully localized option for Japanese submissions and Japanese operating systems.

EZsubs assures alignment with the latest regulatory guidance’s, providing a solution for submissions to worldwide regulatory agencies, with submission templates for quick and easy assembly including CTD/eCTD templates.

In addition to offering improved efficiency of the entire regulatory publishing process and streamlining the reuse of information, EZsubs offers the following features :

• Streamlined and seamless eCTD publishing
• Compile simultaneous submissions to global agencies achieved by comprehensive built-in templates
• Volumize large paper-based submissions
• Resolve electronic cross references between documents and volumes for electronic submissions
• Conserve resources with support for individual users with “roles based” interfaces
• Network optimization tools for globally distributed teams on corporate networks
• Transform file formats to PDF while maintaining full page fidelity
• Achieve site driven load balancing for rapid performance
• Operate with low footprint and low load on the corporate IT systems
• Achieve faster installation and deployment then any other software on the market.
• Utilize the Unicode base for complete Japanese submissions.

EZsubs provides an effective and highly reliable publishing tool to support your organization during mission critical submission periods. 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

The EZsubs eCTD module includes rich functionality offering customers who already have, or are going to deploy the Documentum content management system, the capabilities to manage their electronic submissions. The XML generator enables users to map the life-cycle of the product to the related documentation through Documentum. With cross-referencing at the authoring level, users are able to insert, manage and maintain cross-references as each document in the submission evolves, which is critical to the electronic submission.

EZsubs enables companies to:

• Easily convert prior submissions to new eCTD format
• Seamlessly transition from submissions currently in process
• Quickly assemble an eCTD from scratch
• Generate the XML structure on the fly
• Refine submission structure with author and publishing level advanced cross- referencing capabilities.