Aris Global Deploys Register™ for Regulatory Approval Tracking at Novo Nordisk

Business Wire,  June 23, 2008  

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Single solution streamlines planning and managing global regulatory activities and mitigating risk

BOSTON -- Aris Global, a leading provider of software solutions for the life sciences industry, today announced that Novo Nordisk, a world leader in diabetes care, implemented Register[TM] as their standard for regulatory information management, providing a global and uniform process for determining regulatory action and status. Register is a Web-based regulatory solution that offers a central repository for managing the end-to-end tracking of product registration details and submissions.

Prior to implementing Register, Novo Nordisk had three separate systems for planned submission activities, change request handling, and product approval information. With the implementation of Register, Novo Nordisk's Regulatory Information Management System (RIMS) now centrally distributes registration data to the local affiliates, dramatically reducing manual data entries in affiliates and improving the quality of regulatory data for reports and better informed business decision making. The comprehensive change request handling gives Novo Nordisk a single point of entry for change request and product impact analysis. Register automatically links the status of the change request to the submission status and provides the approval status in the batch allocation and batch release processes.

During the development and implementation phase, NNIT - a leaning Danish IT services provider to the pharmaceutical industry - acted as a trusted advisor for Novo Nordisk to ensure that the new system complies with Novo Nordisk business needs and GxP standards. NNIT designed and executed the data transfer of the large amount of business critical data which was transferred from the old system to the new Register system. Furthermore NNIT was responsible for validation of the system and also ran a large amount of training and change management activities in cooperation with Novo Nordisk. NNIT will be running the support and maintenance of the system.

"Regulatory tracking can be extremely manual and complex due to new products, production sites, markets and ongoing product maintenance," said Peter Bonne Eriksen, senior vice president, Regulatory Affairs, Novo Nordisk. "Register facilitates managing the regulatory tasks coming from development of new products, modifications to production, labeling changes and authority commitments. We worked very closely with Aris Global and now have a cohesive regulatory information management system in production that will ensure our compliance with a high degree of efficiency and automation."

"From an IT point of view, Novo Nordisk has replaced several manual procedures as well as disconnected and outdated IT systems with one sustainable system that is integrated with other IT systems managing product changes, logistics and limitations. This provides a much more effective IT landscape that facilitates the possibility to harvest the business benefits" says Bjarke M. Christensen, corporate vice president, Pharma Solutions, at NNIT.

Novo Nordisk has more than 450 users accessing the Register system across various business and regulatory functions. Regulatory Affairs in headquarters and in the affiliates leverage Register for operational planning of regulatory activities and maintenance of regulatory status, such as application type, submission and approval dates. Those in Logistics check the approval status in specific countries before making batch allocation and verify registration details of product, such as manufacturing sites, shelf life and specifications. Quality Assurance at sites rely on Register for releasing a batch.

"We are very excited about Novo Nordisk's implementation of Register for managing their product portfolios and regulatory affairs activity on a global basis," added Tamir Sigal, product marketing manager, Aris Global. "Companies today are faced with using multiple and manual processes to plan and manage their regulatory submissions and Novo Nordisk is a great example of how organizations can streamline the processes associated with regulatory submission and management of the disparate sources of information."

About Novo Nordisk

Novo Nordisk (www.novonordisk.com) is a healthcare company and a world leader in diabetes care. In addition, the company has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society.

With headquarters in Denmark, Novo Nordisk employs approximately 26,000 employees in 80 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'.

About NNIT