First eCTD submission in ASEAN, Thailand’s FDA announces pilot electronic submissions project with LORENZ docuBridge®
Bangkok, 20 May 2014 // The LORENZ docuBridge® software solution together with Factorytalk Co., Ltd have been selected by the Thai Food and Drug Administration (FDA) to receive, review and process electronic applications for market authorization under the Drug Control Division. This marks an important milestone in Thailand’s move to e-submissions, and the Thai FDA will work with stakeholders throughout 2014 to introduce the new system.
LORENZ docuBridge® is the most established standard solution in small, medium and large companies as well as regulatory agencies for compiling, publishing, managing and reviewing electronic submissions. The software complies with all global eCTD standards and NeeS.
“We’re very proud that the Thai FDA 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, the EDQM (European Directorate for the Quality of Medicines & Health Care) and the German Federal Institute for Drugs and Medical Services (BfArM). We’ll be using that global experience to help ensure that the transition from paper to electronic submissions in Thailand runs as smoothly as possible.”
“It is an honor that the Thai FDA have selected us to implement this highly important project together with our partner LORENZ and their docuBridge® solution to improve the efficiency and quality of regulatory submissions in Thailand” says David Margetts, Managing Director, Factorytalk Co., Ltd. “The submissions process is a fundamental control in the supply and manufacture of regulated products, and this project will have great benefits to improve application times for critically important products such as pharmaceutical medicines. It will also ensure a complete accordance to the eCTD as standard across Europe, US and the World. Effective submissions management using the docuBridge® solution is a basis for ensuring the highest quality of imported and locally manufactured goods for Thailand. We are proud and dedicated to deliver this key assignment for the country together with our trusted partner LORENZ”.
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. LORENZ docuBridge® is the most widely used eCTD submission management system for U.S., European and Japanese formats among many others, and is popular with regulatory agencies and industry alike. With over 300 installations in over 25 countries, LORENZ has a strong worldwide customer base.
About Factorytalk Co., Ltd
Factorytalk was founded in Bangkok, Thailand in 2004 and has since expanded rapidly across the SE Asia region with locations in Singapore, Jakarta and Kuala Lumpur. Factorytalk provides services and solutions to regulated companies in Asia by focusing on operational excellence technology to increase performance and deliver compliance efficiencies. Factorytalk’s consultants are specialists in the optimization of quality management systems to meet the most stringent of international regulations and provide a wide range of technical expertise across the regulated industries including: project management, risk assessment, validation, designing and implementing large scale IT solutions, training, offshoring/insourcing and audit and inspection support. For more information about Factorytalk, visit www.factory-talk.com, or call: +66-2630-4525 ext 55. (Thailand); +65 6408 8000 (Singapore); +603 2615 7397