eCTD Solution for Regulatory Submission Lifecycle

CDC Solutions Launches Complete eCTD Solution to Manage The Entire Regulatory Submission Lifecycle

Sophisticated eCTD Solution Unveiled at Momentum 2002 in Orlando, FL

Orlando, FL, USA. September 12, 2002.

CDC Solutions Ltd. (www.cdcsolutions.com), the leading global provider of document-based solutions to the life sciences industries, today launches a complete solution to accommodate life sciences organizations in meeting the challenge of managing and publishing regulatory submissions according to the emerging specifications of the electronic Common Technical Document (eCTD). Unveiled for clients, partners, and potential customers at Momentum 2002, CDC's sophisticated eCTD solution solves the mission-critical steps in managing the entire submission life cycle while providing the ability to quickly adapt to change as the eCTD format evolves in the future. Included in the EZsubs Submission Manager, the eCTD solution is designed with an advanced architecture and unmatched flexibility that leverages the proven technology of EZsubs to help ensure organizations meet the regional and International Conference on Harmonization's (ICH) eCTD specifications.

The eCTD is part of the 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 part 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, "CDC has worked closely with the ICH to ensure that our solution for the eCTD helps clients harness existing investments in content and regulatory publishing solutions while also meeting all regional and ICH specifications. CDC is committed to helping our clients streamline their submission process with our new eCTD solution as well as delivering education from our team of regulatory experts."

The eCTD introduces the use of an 'XML backbone' as 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. CDC's eCTD solution provides not only an easy to use XML generator, but all the functionality necessary to map the life-cycle of the product to the related documentation through the organizations' content management system. The eCTD solution works with CDC Solutions' Xref manager to provide advanced cross referencing at the author level allowing users to insert, manage, and maintain cross references as documentation changes with continued product development.

Jim Cook, Chief Technical Officer of CDC Solutions, added, "Organizations are facing major transitions in the underlying business processes due to the new approach required for the eCTD. The process is much more complex than the generation of the 'XML backbone'. Companies must be able to manage the entire life-cycle of the submission, which means that as the product develops documentation changes frequently and all these changes must be tracked and reported to the regulatory agencies. CDC's eCTD solution allows quick refinement to submission structure, cross references and content - all of which is critical to the life-cycle approach of the eCTD."

eCTD Solution Availability

The eCTD Solution will be available to clients 30 days after the ICH reaches the final specifications of Step 4, which is currently planned for mid-September.

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 solution designed to provide organizations with a first-hand look at the eCTD solution. To schedule an onsite demo, email info@cdcsolutions.com. CDC Solutions will also offer free Web-based seminars in September and October to deliver an overview and live demonstration of the eCTD solution. Visit www.cdcsolutions.com/WebSeminars.asp to register.

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 +44 1249 705300 (United Kingdom) or +1 610.834.9021 (CDC Solutions Inc., North America), or visit the CDC Solutions website at www.cdcsolutions.com

Prepared by Robin Cover for The XML Cover Pages archive. See: "Electronic Common Technical Document (eCTD) for Pharmaceuticals."

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(www.cdcsolutions.com), the leading global provider of document-based solutions to the life sciences industries, today launches a complete solution to accommodate life sciences organizations in meeting the challenge of managing and publishing regulatory submissions according to the emerging specifications of the electronic Common Technical Document (eCTD). Unveiled for clients, partners, and potential customers at Momentum 2002, CDC's sophisticated eCTD solution solves the mission-critical steps in managing the entire submission life cycle while providing the ability to quickly adapt to change as the eCTD format evolves in the future. Included in the EZsubs Submission Manager, the eCTD solution is designed with an advanced architecture and unmatched flexibility that leverages the proven technology of EZsubs to help ensure organizations meet the regional and International Conference on Harmonization's (ICH) eCTD specifications. The eCTD is part of the 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 part 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, "CDC has worked closely with the ICH to ensure that our solution for the eCTD helps clients harness existing investments in content and regulatory publishing solutions while also meeting all regional and ICH specifications. CDC is committed to helping our clients streamline their submission process with our new eCTD solution as well as delivering education from our team of regulatory experts." The eCTD introduces the use of an 'XML backbone' as 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. CDC's eCTD solution provides not only an easy to use XML generator, but all the functionality necessary to map the life-cycle of the product to the related documentation through the organizations' content management system. The eCTD solution works with CDC Solutions' Xref manager to provide advanced cross referencing at the author level allowing users to insert, manage, and maintain cross references as documentation changes with continued product development. Jim Cook, Chief Technical Officer of CDC Solutions, added, "Organizations are facing major transitions in the underlying business processes due to the new approach required for the eCTD. The process is much more complex than the generation of the 'XML backbone'. Companies must be able to manage the entire life-cycle of the submission, which means that as the product develops documentation changes frequently and all these changes must be tracked and reported to the regulatory agencies. CDC's eCTD solution allows quick refinement to submission structure, cross references and content - all of which is critical to the life-cycle approach of the eCTD." eCTD Solution Availability The eCTD Solution will be available to clients 30 days after the ICH reaches the final specifications of Step 4, which is currently planned for mid-September. 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 solution designed to provide organizations with a first-hand look at the eCTD solution. To schedule an onsite demo, email info@cdcsolutions.com. CDC Solutions will also offer free Web-based seminars in September and October to deliver an overview and live demonstration of the eCTD solution. Visit www.cdcsolutions.com/WebSeminars.asp to register. 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 +44 1249 705300 (United Kingdom) or +1 610.834.9021 (CDC Solutions Inc., North America), or visit the CDC Solutions website at www.cdcsolutions.com Prepared by Robin Cover for The XML Cover Pages archive. See: "Electronic Common Technical Document (eCTD) for Pharmaceuticals."