State Institute for Drug Control (SÚKL) of Czech Republic will review electronic submissions using LORENZ docuBridge
Praha, 10 November 2016 // The LORENZ docuBridge software solution has been selected by the SÚKL (State Institute for Drug Control) located in Praha, Czech Republic for that agency’s work in receiving, reviewing and processing electronic applications for market authorizations. The SÚKL will combine docuBridge with the LORENZ Automator service for the automated download of electronic submissions from the EMA CR.
“We’re very proud that the SÚKL have placed their trust in us for handling eCTDs and NeeS” says Wolfgang Witzel, President, LORENZ Life Sciences Group. “Our global experience is helping more and more Health Agencies like SÚKL ensure that their review of electronically created submissions runs as efficiently and smoothly as possible. There are also significant advantages in time-saving and in the storage and handling of regulatory files. The fact that SÚKL is coupling docuBridge with the use of LORENZ Automator for its downloads from the EMA is also significant. It marks an important milestone for both LORENZ and the SÚKL.”
LORENZ docuBridge addresses all the fundamental business challenges of an eReview process, and complies with all global eCTD standards and NeeS. The software is already used by many other authorities globally, including Health Canada, the German Federal Institute for Drugs and Medical Services (BfArM), the Australian Therapeutic Goods Administration (TGA), and the Thai FDA.
About SÚKL
The Czech State Institute for Drug Control is an administration body established by the Act no. 79/1997 Coll. It falls under direct control of the Ministry of Health. The scope of operation of the Institute is stipulated by legal regulations. In order to safeguard its tasks, the Institute establishes regional workplaces located outside the headquarters of the Institute. The Institute's mission is, in the interest of public health protection, to ensure that all human pharmaceuticals available on the Czech market meet appropriate standards of quality, safety and efficacy to take share to ensure that only safe and functional medical devices are used in the Czech Republic, in addition, accompanied by reliable and appropriate information. Moreover, its role is to contribute to rational use and where appropriate, to responsible and ethical clinical trials of both medicinal products and medical devices.
Regulatory procedures shall not result in unnecessary obstacles to the availability of medicinal products and medical devices nor to introduction of new therapeutic procedures.
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 has an array of Regulatory Information Management solutions geared towards industry, health authorities and academia which enable enforcing compliance globally. LORENZ's tried and tested portfolio offers Product Registration/IDMP, Submission Assembly, Validation and Management, Publishing/eCTD, Regulatory Planning and Tracking products and related services. Interoperability between LORENZ products and third party solutions, as well as the ability to automate processes allow LORENZ customers to enhance operational efficiencies. With over 600 paid installations in over 30 countries and an average customer growth of 10 new customers per month in 2016, LORENZ has a strong worldwide customer base.