Frankfurt/Main 7 June 2017 // The Boscolo Plaza in Nice, France will be the setting for userBridge.17, the annual regulatory affairs conference hosted by LORENZ Life Sciences Group. Running from 19-21 September 2017, this forum is well-known for showcasing the very latest thinking from the world of regulatory affairs, with high-level speakers recruited to give a wide range of e...
Sarasota, FL / Frankfurt/Main, 28 March 2017 // Generis Knowledge Management Inc. and LORENZ Life Sciences Group today announced that they started a new joint solution integrating their two products CARA and LORENZ docuBridge to support regulatory publishing from Documentum.
This strategic partnership means that Generis and LORENZ can give customers the ability to author and publish with two industry-leading solutions: CARA for authors, and docuBridge for publishers. ...
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 th...
Frankfurt/Main, 19 October 2016 // Hamburg, a seafaring city with a long tradition of international trade was the setting for this year’s userBridge conference, the global e-regulatory affairs gathering organized by the LORENZ Life Sciences Group, the world’s premier supplier of eCTD solutions. Held from 20-22 September, the sold-out userBridge.16 event attracted 172 participants from 21 countries. Interoperability of systems and the importance of converging...
Philadelphia, 07 October 2016 // LORENZ Life Sciences Group is pleased to announce that the U.S. Food and Drug Administration (FDA) awarded LORENZ with an “Electronic Common Technical Document (eCTD) Validation and Review Software” contract on September 30, 2016 through a competitive procurement process.
LORENZ will implement its docuBridge, eValidator and Automator solutions in FDA’s Center for Drug Evaluation and Research (CDER) and Cent...
Pretoria and Frankfurt/Main, 30 September 2016 // LORENZ Life Sciences Group is happy to introduce the latest members to the 1K Club and the first to qualify in Africa. DI Regulatory Consultants and MRA Regulatory Consultants have both recently announced they have compiled over 1,000 submissions using the LORENZ docuBridge system.
"Africa is very quickly adopting the CTD as the standard structure,” said Robyn Daniel, Director at MRA Regulatory Consultants...
Tokyo and Frankfurt/Main, 29 August 2016 // Following the 2nd International Symposium of the Japan eCTD Society on May 24, 2016 in Tokyo, the partner companies Digital Media System and LORENZ initiated a taskforce to work on a knowledge base covering the specific items relating to eCTDs submitted to PMDA, the regulatory agency for pharmaceuticals and medical devices in Japan.
The Japanese eCTD's technical aspects are defined by the written specification and ...
Frankfurt/Main, 13 May 2016 // The Atlantic Kempinski Hotel Hamburg will be the setting for userBridge.16, the annual regulatory affairs conference hosted by LORENZ Life Sciences Group. From 20-22 September 2016 experts from industry and government authorities will gather to network & discuss the latest trends and insights in regulatory affairs based on the userBridge motto LEARN-DISCUSS-INTERACT.<...
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