LORENZ Life Sciences Group // Frankfurt, Germany // LORENZ Life Sciences Group, the largest supplier of eCTDs in the world, announced today that it has won the tender to supply an eCTD review system to the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The tender was designed to accommodate a maximum of 400 users onsite as well as up to 100 users accessing the system externally.

"We are very happy to have won this tender," says Wolfgang Witzel, President of LORENZ Life Sciences Group. "We are steadily growing our agency business and are getting very valuable feedback from agency users as to the required functionality. Adding the Polish agency to our list of customers means that more focus can be put on the agency requirements. We welcome this opportunity to work with the Polish agency."

LORENZ currently supplies eCTD review systems to five agencies around the world, four of whom are in Europe. LORENZ currently foresees a growing trend as the move is away from tool-based approaches to a more holistic business process approach. The LORENZ docuBridge system, which is at the heart of the tender, is able to comply with any type of procedure in the EU (centralized, decentralized, MRP, national), US, Canada and Japan. Further, its configurable export and import modules allow the system to be used in a variety of procedures that are not part of the ICH or EU/North American/Japanese submission architectures.

LORENZ is also the only vendor to ensure just one code-set is used to develop both the industry as well as the agency solution: both are based on the same framework, which significantly reduces support issues and ensures rapid updates to changing regulatory requirements.

The news arrived during the annual LORENZ user conference, userBridge 2009, which hosted 130 delegates from 19 countries. The user conference, by coincidence, was held in Warsaw, Poland and added to the overall very enjoyable and informative event.

For further information, please click here to contact LORENZ.

About LORENZ Life Sciences Group

LORENZ Life Sciences Group (www.lorenz.cc) develops and markets software solutions for the Life Sciences market since 1989. LORENZ's solutions are geared specifically for submission assembly, review, publishing, validation and management. As the number one supplier of submission management systems in the world, as well as the largest supplier of eCTDs for U.S., European and Japanese submissions in the world, LORENZ is the technological market leader. With over 160 installations in 20 countries, LORENZ has built a reputable customer base. For more information, please click here to contact LORENZ.