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FDA awards LORENZ eCTD Contract

Oct2016
07

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 Center for Biologics Evaluation and Research (CBER) electronic submission programs. CDER and CBER will use the LORENZ product suite to validate and review incoming and legacy eCTD submissions.

“We remain dedicated to Engineering the World’s Most Desirable e-Regulatory Solutions,” said Wolfgang Witzel, President LORENZ Life Sciences Group, adding that “it is an honor to be chosen by the FDA and we view this as testament to the quality of LORENZ employees, products and solutions.”

“The partnership between the two organizations will kick off immediately in October 2016 and we will work together to ensure a smooth transition,” said Yaprak Eisinger, Managing Director, North America.

Questions regarding the FDA-LORENZ partnership or other partnerships LORENZ has with leading health agencies around the world can be directed to Jared Lantzy, Manager of Global Regulatory Agencies and Processes, jlantzy [at] lorenz.cc.

 

About LORENZ Life Sciences Group
LORENZ Life Sciences Group 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, Regulatory Planning and Tracking products and related services. Interoperability between LORENZ products and third party solutions, as well as our ability to Automate processes allow LORENZ customers to achieve operational efficiencies their competitors are not used to. To learn how thousands trust LORENZ, go to www.lorenz.cc or www.lorenz.cc/Corporate/index.cfm.

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