LORENZ Chosen by EMEA as eCTD Reviewing System - Again!
GUILDFORD, UK: LORENZ has announced that it was reselected by the European Medicines Evaluation Agency (EMEA) to lead the second pilot phase to introduce eCTD reviewing capability at various authorities within the European Union. This followed a tender issued by the EMEA in which certain core functionality was defined as well as the overall direction. docuBridge and two further tools were chosen allowing certain authorities to better understand the differences between systems. In this second phase, docuBridge will go beyond pure eCTD reviewing, delivering an entire submission management solution and thus providing greater functionality than expected from a ìtoolkitî approach.
"We are delighted that we have been chosen yet again," says Wolfgang Witzel, President & CEO of LORENZ Life Sciences Group."This is the second time in series that we have been chosen and this clearly underlines our performance over the past year." LORENZ is the only vendor that has participated in the first pilot phase as well as the second.
docuBridge will continue to be installed at all the remaining authorities that have not yet received the product and a new round of updates is being rolled out in parallel.
The second pilot phase will lead to a further understanding of the electronic submission process at the various regulatory agencies and will conclude in November 2005. This also comes in view of the announcement by the EMEA that they are aiming for non-mandatory paperless submissions by November 2005.
LORENZ remains committed in providing best-of-breed solutions to both industry and agency, the experience from both is helping to shape the future product development. The rapid implementation and training methodology helps authorities and companies alike in reaching productivity fast.