The European Directorate for the Quality of Medicines & HealthCare (EDQM) has selected the LORENZ eCTD review system for the management of electronic applications for their certificates of suitability to the monographs of the European Pharmacopoeia (CEP). The EDQM will use LORENZ iSubmit® and LORENZ docuBridge® software, which are intended to receive and manage the different formats of electronic submissions received at the EDQM Certification Division (eCTD, NEES or PDF files), and to facilitate the review by the assessors.
The EDQM has been satisfied with the customer-oriented approach of LORENZ when selecting the tools, and is looking forward to using them for the efficient management of e-submissions from all over the world. More information about EDQM requirements for e-submissions related to CEP applications is available on the EDQM website: www.edqm.eu

"We are very proud to have won EDQM as an agency customer," says Wolfgang Witzel, President of LORENZ Life Sciences Group. "EDQM receives a variety of submission formats from applicants all over the world and we were able to demonstrate to EDQM that LORENZ docuBridge provides the best functionality to cope with their requirements. With the experiences gained from over 20 years of working with and within agencies, we will support the workflow and management of e-submissions at the agency in a way like no other software vendor could do."
LORENZ currently supplies eCTD review systems to six agencies around the world, five 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, and its configurable export and import modules are able to comply with any  type of e-submission submitted to the agency.
LORENZ is also the only vendor to ensure just one code-set is used to develop both the industry as well as the agency software solution. Both are based on the same framework, which significantly reduces support issues and ensures rapid updates when regulatory requirements are changed. 

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 170 installations in 20 countries, LORENZ has built a reputable customer base. For more information, please click here to contact LORENZ.