CDC Solutions and Octagon Research offer regulatory submissions and consultancy tool

Life Sciences customers to benefit from combined expertise of leading electronic publishing provider and regulatory consulting and services vendor

CDC Solutions Ltd., a world-leader in multi-channel content delivery for regulatory and enterprise-scale publishing, and Octagon Research Solutions Inc. (Octagon), a rapidly-growing research and consulting firm focused on electronic submissions built upon a regulatory foundation, recently announced an alliance designed to provide a complete solution for electronic regulatory publishing and submissions consultancy to Life Sciences customers. Utilizing EZsubs, the highly scaleable publishing software from CDC Solutions, the two companies have begun to incorporate the complete publishing and support solution to current customers, and plan to extend the total package of services to prospective clients as well.

Jim Walker, president of Octagon said, "Octagon Research is excited to partner with an industry leader that shares our vision of delivering benchmark services and solutions to its customers. The goal of this strategic alignment is to deliver leading publishing solutions via CDC Solutions' EZsubs publishing software, coupled with our regulatory background and support through the submissions development process. It's a very positive situation for both companies as well as for our clients."

Octagon, based in Plymouth Meeting, PA, has extensive experience with regulatory submissions, particularly electronic submissions, as well as clinical information management and submission document preparation. CDC Solutions sought to partner with an emerging leader in submissions consultancy that would immediately enhance its overall customer support structure throughout the entire New Drug Application (NDA) and Investigational New Drug (IND) submissions processes, and expand its offerings to include the growing area of complete regulatory submissions development and support. CDC Solutions identified Octagon for its understanding of the complexities of introducing an electronic regulatory system across functional, national and global boundaries, recognizing the opportunity to offer customers a complete, one-stop regulatory submissions development, publishing and consultancy service.

Dave Cornwell, senior vice president and co-founder of CDC Solutions said, "CDC Solutions has developed a specialty in electronic publishing, particularly in a regulatory environment, and we have always provided outstanding regulatory support to our customers. As we proceed with our growth strategy, we want to ensure that our customers continue to receive the regulatory analysis and support they require. Through carefully developed relationships with other industry experts like Octagon, CDC Solutions can maintain its leadership position in electronic publishing while offering its customers expanded services and complete submissions solutions."

Nearly 80 percent of Octagon's employees bring hands-on regulatory and submissions experience to the partnership. Octagon provides the pharmaceutical and biotech industries with experienced professionals who have managed the entire drug development process - from compound identification to final marketing clearance. Octagon's staff has submitted paper and electronic original NDA submissions across multiple reviewing divisions and therapy areas to both national and international regulatory authorities, as well as in excess of 50 original INDs. Octagon's expertise in providing the tools to facilitate and expedite the collection, processing, and submission of product information to regulatory agencies attracted CDC Solutions to the relationship.

Don Palmer, senior regulatory product specialist at CDC Solutions added, "CDC Solutions was particularly interested in Octagon's depth of regulatory experience. The people at Octagon have been in the trenches, working on all sizes of submissions at a variety of life sciences companies, and have prepared hundreds of submissions, garnering the type of experience that can't be readily duplicated. Octagon represents a strong complement to CDC Solutions' regulatory submissions products."

About Octagon Research Inc.
Founded in 1999 as a Development Partnering Organization (DPO), Octagon Research Solutions Inc. (Octagon) is built on Regulatory Principles integrated into the various disciplines of drug development. Octagon's leadership team is intimate with regulatory agencies and issues, and is therefore able to offer its clients customized solutions resulting in time and revenue savings at all levels of the drug development process. Octagon approaches all drug development work from a regulatory perspective, concentrating on the end-result - the regulatory submission - eliminating much of the rework and costly delays that occur if each task is performed in a vacuum.

Octagon's model for efficient submissions has been well proven in the electronic submissions environment, and has since been integrated into other lines of the business. Core services include regulatory affairs, electronic submissions, clinical information management, medical consulting, training, and information technology customization. Consulting and production are available as an outsourcing project or with an on-site team of experienced professionals working as an integrated group within the client's team.

Through integration of technology in an evolutionary fashion within the different functional areas, Octagon enhances regulatory systems and procedures and ultimately facilitates an improved approval process. For more information, call 610.825.0825 or visit Octagon on the Web at www.octagonresearch.com .

About CDC Solutions Ltd.
CDC Solutions is a world-leading provider of multi-channel content delivery publishing solutions that accelerate the assembly, dissemination and publishing of enterprise-scale publishing for paper, Intranets and the Web. Founded in 1994, CDC Solutions has since guided companies on Corporate Publishing techniques and offered a range of solutions that comply with industry formats including XML, HTML, PDF, TIFF, GIFF and JPEG. Working closely with global partners such as Documentum Inc., Adobe Systems, Lotus and QUMAS, CDC Solutions has built an enviable reputation for high quality advanced technology coupled with an unrivaled team of experienced consultants and implementers to deliver corporate knowledge benefit.

CDC Solutions' electronic publishing products are in use by leading Pharmaceutical, Finance, Insurance, Utilities, Automotive and Media organizations both on a departmental and an enterprise level. Today, CDC Solutions is defining the way organizatio ns publish corporate knowledge from simple personalized documents to high-scale regulatory submissions. For more information, call +44 1291 635400 (United Kingdom) or 610.834.9021 (CDC Solutions Inc., North America), or visit the CDC Solutions website at www.cdcsolutions.com .

Source: CDC Solutions

Subscribe to our free e-mail newsletter.

Click for a free Buyer's Guide listing.