The U.S. Food and Drug Administration is now using LORENZ docuBridge and eValidator. The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, are both using the LORENZ solutions now to process incoming as well legacy submissions.
FRANKFURT, Germany and SILVER SPRING, Md., Nov. 2, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (USFDA) is now using LORENZ docuBridge and eValidator. The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), are both using the LORENZ solutions now to process incoming as well legacy submissions. The eValidator validates all incoming submissions for technical compliance, and docuBridge is used to review submission content in the context of the entire life cycle of an application.
This ‘go-live’ concludes a lengthy process that began in 2016, when LORENZ won the FDA’s first tender for a submission review solution, and won again in 2017 when a second tender was issued in response to protests following the first.
During the first stage of the project all 1.2 million legacy sequences were migrated into docuBridge, with all incoming sequences thereafter being imported on a regular basis, adding up to 1.5 million sequences. The migration took only 16 days. This year, amidst the challenging COVID-19 pandemic, over 4,000 reviewers at the CDER and CBER were trained virtually on how to use the LORENZ solutions for maximum efficiency in their everyday validation and review processes.
“We are deeply gratified that the US FDA has placed their trust in us,” said Wolfgang Witzel, President of LORENZ Life Sciences Group, “and we are sure we have delivered a range of high-quality solutions that will allow the CDER and CBER to validate and review submissions much more efficiently. We are happy to welcome the US FDA to the LORENZ ecosystem.”
With the go-live of docuBridge at the USFDA all companies using LORENZ docuBridge for their submission management needs now have a seamless submission process from assembling, approving, publishing and submitting via the gateway to the reviewers using docuBridge. For companies not using docuBridge, LORENZ offers a review only package to leverage the three key advantages of visibility, collaboration and peace of mind. This package is limited to reviewing functionality, and can be upgraded to a full submission management solution. Read more about it here.
“Now that this important milestone has been achieved, the LORENZ and USFDA teams look forward to closer collaboration, specifically in the area of eCTD 4.0,” said Yaprak Eisinger, Managing Director, North America of LORENZ Life Sciences Group. For more information on LORENZ’s RIM portfolio, please visit LORENZ’s website.
For more information on this project please contact LORENZ.
About LORENZ
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 that enable compliance enforcement 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 1300 paid installations in 38 countries, LORENZ has a strong worldwide customer base.
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