Australia’s TGA announces move to eCTD submissions with LORENZ docuBridge®
Frankfurt, 28 February 2014 // The LORENZ docuBridge® software solution has been selected by the Australian Therapeutic Goods Administration (TGA) to receive, review and process electronic applications for the authorization of prescription medicines and therapeutic products under the Australian Register of Therapeutic Goods (ARTG). This marks an important milestone in Australia’s move to e-submissions, and the TGA will work with stakeholders throughout 2014 to introduce the new system.
LORENZ docuBridge® is the most established standard solution for small, medium and large companies as well as regulatory agencies to compile, publish, manage and review electronic submissions. The software complies with all global eCTD standards, NeeS, VNeeS, and AMNOG.
“We’re very gratified that the TGA have placed their trust in us for handling the move to eCTDs” says Wolfgang Witzel, President, LORENZ Life Sciences Group. “The LORENZ docuBridge® solution is already used by 10 other authorities globally, including Health Canada and the German Federal Institute for Drugs and Medical Services (BfArM). We’ll be using that global experience to help ensure that the Australian transition from paper to electronic submissions runs as smoothly as possible.”
About LORENZ Life Sciences Group
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing 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 300 installations in over 25 countries, LORENZ has built a reputable customer base. For more information, please click here to contact LORENZ.