Frankfurt, 8 May 2013 // The Center for Devices and Radiological Health (CDRH) is the FDA organization responsible for ensuring the safety of all medical devices and radiation-emitting products that are marketed in the U.S. Since January 1, 2013 the CDRH has been requiring an eCopy – an electronic duplicate of the paper drug or device submission – in parallel to the paper submission, which still remains mandatory.
Currently, about half of all CDRH eCopy s...
Tokyo, 30 April 2013 // “Over the future” was the title of the third Japanese docuBridge user conference hosted by Digital Media System Co., Ltd.; LORENZ's exclusive distributor in Japan. The event attracted more than forty participants from the pharmaceutical industry and regulatory services.
Following dual introductions by Naoko Hayashi, Marketing Manager at Digital Media System Co., Ltd. and Raoul Lorenz, CEO of LORENZ Life Sciences Group, worksho...
Bangkok and Frankfurt am Main, 13 March 2013// Factorytalk, a Thailand and Singapore-based service provider for pharmaceutical companies and LORENZ Life Sciences, the world’s largest supplier of eCTDs, today jointly announced that Factorytalk will market, service and support LORENZ products throughout Southeast Asia.
“Factorytalk’s intimate knowledge of the life sciences market in Southeast Asia and the Pacific opens up new perspectives for us in the...
Frankfurt am Main, 28 February 2013 // Two hands-on workshops recently gave Indian and South African regulatory affairs professionals the chance to compile eCTD submissions using LORENZ docuBridge. Participants also used the software to re-purpose and replicate content for multiple authorities, underlining the overall convenience of the docuBridge solution.
In Mumbai, two separate one-day workshops were held in cooperation with DIA India on 4-5 February. Here, part...
Electric-powered minibus circulates through Frankfurt’s Main Cemetery
Donation from the LORENZ Foundation
Frankfurt am Main, December 20, 2012 // The Main Cemetery of Frankfurt sprawls over more than 70 hectares. The philosopher Theodor W. Adorno, the author Ricarda Huch, the paediatrician Heinrich Hoffmann who created the German children’s tale Struwwelpeter, and countless other personalities have their final resting place he...
Frankfurt am Main, December 19, 2012 // LORENZ Life Sciences Group launched today their groundbreaking new offering in the US market – docuBridge ONE, the eCTD Workstation Solution.
docuBridge ONE is a token-based, single user eSubmission solution downloadable to a user’s workstation from www.lorenz.cc in less than five minutes. “The eCTD expertise we have amassed through having LORENZ docuBridge used in h...
Frankfurter Podium der LORENZ Systemhaus-Gruppe am 5. November 2012 // Dabei sein ist alles, lautet das olympische Motto. Das schließt freilich nicht aus, dass man mit herausragenden Leistungen auch etwas gewinnen kann. So wie Vico Merklein. Der Handbiker, der bei den Paralympics in London Silber im Straßenrennen holte, war am Montagabend Ehrengast unter den mehr als 200 Gästen des Frankfurter Podiums der LORENZ Systemhaus-Gruppe.
Dabei sein ist alles...
Frankfurt am Main, October 25, 2012 // The BfArM (German Federal Institute for Pharmaceuticals and Medicinal Products) announces that it is widening the scope of so-called "eOnly" submissions. Change notices and extension applications will now also be accepted in a primarily electronic format for those approvals that were submitted prior to 31 March 2010. Conditions do apply, and the general requirement to submit certain additional documents in paper form rem...
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