CDC Solutions Prepares Life Sciences Organizations for the eCTD.

Business Editors/Hi-Tech Writers

PHILADELPHIA & CHIPPENHAM, U.K.--(BUSINESS WIRE)--March 20, 2002

Global regulatory publishing solution to meet ICH specifications

and industry needs for the electronic Common Technical Document 

CDC Solutions Ltd. (www.cdcsolutions.com), the leading global provider of document-based solutions to the Life Sciences industries, today announced the extension of its flagship product, EZsubs(TM), to accommodate Life Sciences organizations in meeting the challenge of managing and publishing regulatory submissions according to the specifications of the electronic Common Technical Document (eCTD).

The latest edition of the EZsubs Suite includes the new Submission Manager that offers everything an organization requires to compile an eCTD submission without the need to purchase a new product or support lengthy implementation procedures.

The new eCTD solution was designed with an advanced architecture and unmatched flexibility that not only ensures organizations will meet the demands of the current eCTD specifications, but also the ability to quickly adapt to change as the format evolves in the future.

The eCTD is part of the International Conference on Harmonization's (ICH) initiative to provide a common format for industry to agency transfer of regulatory information that is acceptable across the ICH regions of the United States, Japan, and the European Union.

This initiative is a key component of the primary ICH goal to facilitate a more economical use of human, animal, and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines.

Philip Padfield, Chief Executive Officer of CDC Solutions said, "The eCTD offers great promise for both the industry and the regulatory bodies, facilitating faster compilation and review of submissions on a world-wide basis. This means a streamlined business process for sponsor organizations and more timely access to new drugs for patients and physicians. Though these benefits are invaluable, the transition to the eCTD could be a difficult one if an organization is not prepared. CDC Solutions makes the transition easier by working in conjunction with our customers to develop a user-friendly solution and adhering to guidance from the ICH to ensure compliance. CDC Solutions remains dedicated to providing our customers with unrivaled solutions to meet the most challenging of regulatory demands without missing a beat."

CDC Solutions' existing capacity to facilitate the publishing of the Common Technical Document (CTD) and a decade of XML expertise provides a strong foundation for development of the eCTD. The CTD is the original mandate from the ICH to provide a common format acceptable across the different regions for the submission of regulatory information.

The eCTD takes this a step further by providing the means to create and transport an electronic submission that complies with the CTD structure. The eCTD provides an XML catalogue with links to the actual files in the CTD.

This use of XML is a new way of approaching electronic submissions which benefits both sponsor organizations and agencies by providing the mechanism to record all interactions and highlighting changes between submissions.

Jim Cook, Chief Technical Officer of CDC Solutions added, "CDC Solutions has considerable strength in XML skills with members of our staff working on XML and SGML for over a decade. In addition, we have been working with customers since late 2000 to develop an XML-based electronic submission. This experience has provided us with a solid roadmap for development of an easy-to-use eCTD solution. Our customers can create an eCTD submission using the EZsubs Submission Manager similarly to the way they would create a submission in another electronic or paper format. This approach will dramatically reduce the learning curve which will help ease the transition organizations face when adjusting their working practices to rise to the challenge of the eCTD."

CDC Solutions' technology and regulatory experts have contributed to the ICH on the development of the specifications for the CTD and the eCTD. In addition, CDC Solutions is working with high-level regulatory and IT professionals from global Life Sciences companies to continually enhance the eCTD solution.

This valuable customer input, coupled with close development of the EZsubs Submissions Manager with ICH specifications, has resulted in a flexible, easy-to-use eCTD solution to help ensure organizations transition smoothly into the future of electronic submissions.

Products and Availability

eCTD Demonstrator - The latest edition of the EZsubs Suite will ship with the eCTD Demonstrator in April 2002. The eCTD Demonstrator enables companies to gain practical experience compiling an eCTD submission prior to the finalized specifications from the ICH, due out in late 2002.

eCTD Solution - The eCTD Solution is scheduled for inclusion in the next EZsubs Suite release, presently planned for September 2002, and will be upgraded to meet any additional eCTD requirements as specified by the ICH in the final steps of the process.

Professional Service Offerings

eCTD Readiness Check - The eCTD Readiness Check is a four-phase consultancy program designed to inform and educate organizations on the eCTD and its business implications. Education will be followed by a capability assessment and an action plan for organizations to take full advantage of the eCTD benefits.

Product Demonstrations

CDC Solutions is offering an on-site presentation of the eCTD Demonstrator designed to provide organizations with a first-hand look at the eCTD solution. To schedule an onsite demo, email [e-mail].

CDC Solutions will also offer free Web-based seminars on Tuesday, April 23, 2002 to deliver an overview and live demonstration of EZsubs Submission Manager and the eCTD solution. To register, visit www.cdcsolutions.com/WebSeminars.asp.

About CDC Solutions Ltd.

Founded in 1994, CDC Solutions is the leader in high performance document-based solutions to the Life Sciences industries. The open, flexible technologies developed by CDC Solutions enable Life Sciences companies to meet the strict standards of regulatory authorities across the world, helping them achieve quality, accuracy, and data integrity to deliver reports and submissions reliably on time.

CDC Solutions helps compress the regulatory submissions and approval process, improving speed to market, cost control, and productivity: all of which contribute to ensuring patients' and physicians' timely access to new drugs.

CDC Solutions develops products in-house, employing a team of developers and regulatory specialists who actively pilot new initiatives with clients and partners. Through its strategic business partners, CDC Solutions' technology is used to address the needs of other document intensive industries such as engineering, utilities, and finance.

For more information, call [phone] (United Kingdom) or +1 610.834.9021 (CDC Solutions Inc., North America), or visit the CDC Solutions website at www.cdcsolutions.com.

CDC Solutions, CDC Solutions Inc., EZsubs Publishing Suite, PDFfusion, PDFrender, PDFaqua, PDFtools, PDFcontrol, Xport and Xtensia are trademarks or registered trademarks of CDC Solutions Ltd. All other product and company names mentioned herein are trademarks of their respective holders.