ArisGlobal LLC

October 26, 2005 11:00 ET

Novo Nordisk to Implement Register™ From ArisGlobal® For its Regulatory Information Management System

STAMFORD, Conn.--(CCNMatthews - Oct 26, 2005) -

ArisGlobal, a leading provider of safety, pharmacovigilance, regulatory, and medical information solutions, today announced that Novo Nordisk A/S, a world leader in diabetes care, has selected Register™, as the backbone of its Regulatory Information Management System (RIMS).

A customized new version of Register™, will be developed for product registration, change control and the management of regulatory information at Novo Nordisk A/S to improve the company's ability to release batches on a consolidated and reliable data basis while also improving the company's operational efficiency in batch allocation, batch release and Regulatory Affairs. The adoption of RIMS is also intended to improve manufacturing and logistic compliance efforts and enable increased leverage over the product portfolio.

Register™ is a web-based regulatory solution that manages product registration details and submissions. Register's central repository drives compliance throughout the enterprise, providing a global view of product registration, manufacturing, and marketing details of pharmaceutical products.

Novo Nordisk A/S is a health care company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition, Novo Nordisk has a leading position within areas such as homeostasis management, growth hormone therapy and hormone replacement therapy.

"Novo Nordisk is strategically focused on defeating diabetes by finding better methods of diabetes prevention, detection and treatment. We wanted to work with a best-of-breed company that will deliver a regulatory management and tracking system that would enable us to meet our goals," says Mr. Peter Bonne Eriksen, Senior Vice President of Novo Nordisk's Regulatory Affairs. "We selected ArisGlobal because it offers a comprehensive regulatory information management system that support worldwide submissions, country affiliate planning and full compliance between what is approved and what is manufactured, "says Mr. Eriksen. "As a company developing a wide range of the most advanced products within the area of insulin delivery systems, there exist unique demands of regulatory compliance, in the United States with the FDA, and with numerous other local, regional and international regulatory agencies here within Europe," said Simon Sparkes, Vice President of European Operations at ArisGlobal. "ArisGlobal's Register™ has been built to support regulatory compliance, optimize processes throughout the product lifecycle, and foster collaboration between headquarters, country affiliates, and partners--functions that align well with Novo Nordisks' priorities."

About the Company

ArisGlobal LLC is a leading provider of Pharmacovigilance and Safety, Registration Information Management, Clinical Trials Management and Medical Communications software solutions to the pharmaceutical, biotechnology, medical device and clinical research organization (CRO) markets. ArisGlobal life sciences software solutions are being used by over 100 life science companies including major pharmaceutical companies across the world. ArisGlobal software helps companies meet international regulatory requirements, manage risk, improve operational efficiencies and easily share mission-critical information on a global basis.

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