LORENZ solutions offer you the flexibility of deployment either in the cloud or on-premises. To continue offering our customers the best possible service with our cloud-based solutions, we are renewing our infrastructure and switching to Amazon Web Services (AWS).
The advantages you enjoy with LORENZ Cloud include:
UPDATE: LORENZ regretfully cancels LORENZlink 2020. Click here to read more.
The LORENZlink 2020 RIM conference is taking place from April 21-22, 2020 in Vancouver, Canada.
Our two-day conference will feature presentations and tutorials by many distinguished LORENZ customers, partners and employees. The agenda includes a range of hot topics from prominent experts. See some highlighted topics below or the whole agenda by clicking here.
After the two-day conference, you can join us for the the optional day (April 23, 2020) of docuBridge training!
Register here for the conference or here for the training day.
LORENZ has implemented a publishing module for EAEU submissions in docuBridge based on the EECB No. 79 specifications and the R.022 schema. Interested customers can connect to LORENZ Cloud for an early glimpse on how to publish EAEU submissions. Please contact your Account Manager for further information. The publishing module will be continually updated to reflect any further specification changes. The EAEU submission publishing will soon be commercially available as a normal docuBridge publishing module. Continue reading
The CDE, China’s regulatory agency conducted an eCTD pilot from November 25th through December 4th 2019. A selected number of industry companies were nominated to submit electronic submissions in eCTD format (CN v1.0 DRAFT). Continue reading
The releases of docuBridge, drugTrack and eValidator are available!
What´s new in docuBridge? Several features have been improved, and we have made the webAccess Module, the web-based docuBridge, available to all docuBridge FIVE customers. webAccess now includes both the webAccess Submission Workbench and the new webAccess Explorer. Furthermore, docuBridge now lets you save time by offering an automated compilation option based on meta-data. Last but not least, the Document Management capabilities have been enhanced to help authors to standardize the authoring process. Click here to read more about these highlights: What´s new in docuBridge 19.2?
What´s new in drugTrack? This release features a wide range of improvements and one completely new module to make your work life easier. Via the new Master File Tracking module, you can track Drug Master Files in the US or Active Substance Master Files in Europe. We have also increased the number of standard reports, giving you a wider selection of pre-defined and detailed reports. In addition, should your company have more specific requirements, you have now the ability to create customer-defined configurable business objects. To make your workflow more fluid, we have enhanced drugTrack´s Warnings and Notifications for Marketing Authorizations. Click here to read more about these highlights: What´s new in drugTrack 19.2?
What´s new in the eValidator? We have made updates and corrections for CA eCTD, US eCTD and eCopy, CN eCTD, JO eCTD, CH eCTD, AU eCTD, EU eCTD, GCC eCTD, TH eCTD, and ZA eCTD.
On September 17, 2019, the official website of the CDE of the Chinese NMPA began soliciting public opinions on the preliminary draft of eCTD submission guidelines, the supporting eCTD technical specifications, verification standards and other related documents. The deadline for submitting opinions is October 17, 2019. Please provide your feedback before this closing date.
Previously, the draft eCTD specifications and validation criteria had been issued for advice in March 2019. This second round of public consultation signals that China is now in the final stage of eCTD preparation, and that the eCTD pilot phase will soon be launched. This means that companies should be fully prepared to implement eCTD submissions, and possibly willing to participate in the pilot.
For the original notification from CDE, please click here.
This year’s userBridge conference in Athens, Greece is already sold out!
As a registered participant, you can look forward to a wide range of regulatory affairs perspectives from agencies, industry and prominent consultants.
Established under the overall theme “Learn, Discuss and Interact”, the conference covers a wide variety of presentations and tutorials focusing on practical solutions for current challenges regulatory and IT professionals face. Find here two interesting abstracts which you can find on this year’s agenda.
For the final LORENZ userBridge 2019 agenda please click here.
Update on eCTD for China
In summer 2017, China was approved as the eighth regulatory member of the ICH. Since then, China’s regulatory landscape has undergone a transition of incredible scope and speed. A draft specification was published in March 2019, and we expect the launch of eCTD in December.