DNAnexus and LORENZ Partner to Enable Collaborative Regulatory Submission Validation and Scientific Review in the Cloud via Trusted Regulatory Spaces
Companies have joined with industry leaders and FDA on Project PRISM to advance solutions that can improve the submission, review and ease of communication for human drug and biologics applications
MOUNTAIN VIEW, Calif. & FRANKFURT, Germany — Feb. 12, 2024 — DNAnexus, Inc., provider of the Precision Health Data Cloud, and LORENZ Life Sciences Group, the leader in regulatory information management technology for the life sciences industry, today announced a partn...
LORENZ docuBridge, eValidator and Automator selected by the Singapore HSA for an eCTD Reviewing Solution
Frankfurt/Main, Germany and Singapore, Singapore, June 7, 2023 // The consortium of LORENZ Life Sciences Group, VRG Pte. Ltd. & WebSparks Pte. Ltd. has been awarded the contract to provide an eCTD reviewing solution to the Singapore Health Sciences Authority (HSA). This solution will receive and review eCTD dossiers and assist in the development of a regional schema and eCTD specification.
The consortium will provid...
LORENZ docuBridge, eValidator, and Automator go live at the USFDA
Frankfurt/Main, Germany and Silver Spring, MD, November 2, 2020 // 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 as legacy submissions. The eValidator validates all incoming submissions for technical com...
LORENZlink 2020, LORENZ's RIM conference in Vancouver
Frankfurt/Main, January 31, 2020 // LORENZlink, LORENZ’s North American Regulatory Information Management Solutions Conference will take place during April 21-22, 2020 in Vancouver, Canada. While the first 2 days of the conference will feature presentations and tutorials held by a distinguished faculty of LORENZ customers, partners and employees, participants will also have the option to remain for an additional day of ha...
LORENZ docuBridge FIVE Review Package: See What The Regulators See!
Frankfurt/Main, October 28, 2019 // LORENZ is proud to announce that it will be launching a new pre-configured LORENZ docuBridge FIVE package, limited to reviewing functionality and applicable for all regions currently accepting eCTD. The review package is easily upgradeable to a full Submission Management Solution and/or end-to-end RIM solution for those customers looking to expand capabilities.
It comes with three im...
userBridge.19 underlines worldwide growth of the e-Regulatory Affairs Sector
Frankfurt/Main, October 9, 2019 // More than 180 delegates from 25 countries attended the fully sold-out userBridge.19 conference from September 17-19, 2019 at the Divani Apollon Palace Hotel in Athens. This annual gathering hosted by the LORENZ Life Sciences Group has become the world’s leading regulatory affairs forum, drawing high-powered speakers and participants from industry, health authorities, and consultants.
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userBridge.19 in Athens, Greece from 17-19 September 2019: Save the date and register now!
Frankfurt/Main, June 14, 2019 // The userBridge regulatory affairs conference hosted by LORENZ Life Sciences Group will take place in Athens, Greece from 17-19 September 2019. This annual gathering attracts and showcases the latest thinking in regulatory affairs, offering a range of perspectives from agencies, industry and prominent consultants. The event is also structured to allow generous time for one-on-one networking. Many...
LORENZ and ERIS co-host successful eCTD workshop in Beijing
Frankfurt/Main and Beijing, June 12, 2019 // LORENZ and ERIS recently co-hosted the successful “2019 China eCTD Management and Application Workshop” in Beijing. The event was designed to assist pharmaceutical companies in structuring their submission management processes to meet China’s upcoming eCTD requirements. Participants received comprehensive training in the relevant eCTD submission management regulations an...