Publishing Software manages submission standards.

Press Release Summary:



EZsubs(TM) v5.0 scaleable publishing solution is designed to facilitate regulatory submissions to agencies throughout the world. It manages new and emerging standards, such as electronic Common Technical Document, and role-centric interfaces designed to facilitate easier use. Tools and templates enable submission managers to create new dossier based on industry standard format.



Original Press Release:


CDC Solutions Launches EZsubs 5.0 to Manage New and Emerging Regulatory Submissions


- Advanced software solution meets the demands of the Life Sciences industries -

PHILADELPHIA, PA and CHIPPENHAM, U.K. - February 5, 2002 - CDC
Solutions Ltd. (www.cdcsolutions.com) , a global leader in regulatory and enterprise content publishing, today announced the release of EZsubs(tm) 5.0, its flagship scaleable publishing solution designed to facilitate regulatory submissions to agencies throughout the world. Among the significant enhancements of EZsubs 5.0 is the ability to manage new and emerging submissions standards, such as the electronic
Common Technical Document (eCTD), and role-centric interfaces designed to facilitate easier use. EZsubs also facilitates template-driven submissions in several countries simultaneously.

These initiatives and process drivers have led CDC Solutions to build on the proven, stable, non-proprietary and extensible architecture of the EZsubs product suite, and further reinforce the position of Ezsubs as the platform of choice for building the publishing solution of the future. EZsubs is designed to work with Documentum's content management infrastructure or as a stand-alone solution.

Philip Padfield, Chief Executive Office of CDC Solutions said, "As companies work on dossier submissions on a global scale, using globally distributed and replicated document repositories, they need faster and more efficient publishing solutions. As an industry, we need to be ready for the shift in requirements to the eCTD standard. EZsubs 5.0 answers this call, and provides new methods of enabling administrators and users with the ability to localize the publishing operations. In
other words, it compresses time to market, which means improved
revenues."

During the initial stages of the development of the eCTD standard, CDC Solutions has been actively involved in the review of the documents that have been published by the International Conference for Harmonization (ICH), via feedback and presentation of its publishing perspective to both European and U.S.-based pharmaceutical companies and regulatory agencies.

Jim Cook, Chief Technical Officer of CDC Solutions said, "In
acknowledging the need for bringing a product to market that
demonstrates a level of compliance with the draft eCTD standards, our approach has been to develop working models and trial products that demonstrable functionality. This coupled with our existing CTD templates for paper-based submissions means that our customers can gain valuable experience in the creation of eSubmissions to eCTD standards."

"Equally important," added Padfield, "is the fact that we can do this in parallel with the ICH process. As soon as Step 4 is reached we will fully release the eCTD module allowing our customers to use our CTD templates and start publishing immediately. So, users will be up and running quickly without the need to reconfigure entire systems, as with some other solutions. The benefit is that our customers will be able to get drugs to market faster - contributing to ensuring patients and physicians timely access to new drugs."

Key New Features

New functionality and features of EZsubs 5.0 include:

* Additional role-centric user interfaces - the provision of
Interfaces specifically designed for a particular user-role within the dossier publishing process

* Tools and templates - Enable submission managers to quickly create a new dossier based on an industry standard format, simplifying the generation of new dossiers

* Fully operational trial product to enable the demonstration of eCTD capabilities - the EZsubs architecture will allow features of this emerging standard to be explored, including the creation of complete eCTD submissions

* Publishing optimization for enterprise networks - support for
publishing by globally distributed teams on corporate networks

Product Availability

EZsubs is now generally available for shipment to customers. For
pricing and additional information, contact CDC Solutions at +44 1291 635400 in Europe or +1 610.834.9021 in the U.S.

About CDC Solutions Ltd.

Founded in 1994, CDC Solutions is the leader in high performance
document-based solutions to the Life Sciences industries. CDC
Solutions' open, flexible technology enables information assets to be assembled, published, and repurposed for optimum value. Offering both "out of the box" solutions and seamless integration with Documentum, CDC Solutions' technologies retrieve information from virtually any source format for automatic conversion into high-fidelity renditions that can be easily combined or distilled to meet every need. CDC Solutions is dedicated to delivering solutions that meet the strict
standards of regulatory authorities across the world, and enabling users to achieve quality, accuracy, and data integrity to deliver reports and submissions reliably and on time. Through its business, partners, CDC Solutions' technology is used to address the needs of other document intensive industries such as engineering, utilities, and finance.

Today, CDC Solutions offers the most advanced publishing technology in the global Life Sciences arena. No other provider can come close to matching the flexibility and dexterity of CDC Solutions' products, or equal the comprehensive support services delivered by its expert services teams in both Europe and the U.S.A.

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