Posted on April 30, 2021
The April releases of docuBridge, drugTrack and eValidator are available!
What's new in docuBridge? A range of improvements have been made. With the LORENZ Menu, you now have a single point of access for all your LORENZ web products, including the new LORENZ Help Center, the new LORENZ Dashboard, and the LORENZ adminPanel. As for the new LORENZ Dashboard: You can now use it to visualize all of your data so you can see the information relevant to you at a single glance. In addition, you can now start using the new Taiwan M1 eCTD v1.0 specification. Click here to read more about these highlights: What's new in docuBridge 21.1?
Posted on April 22, 2021
Have you ever dreamed of your to-dos simply taking care of themselves? Then we have the solution for you!
The LORENZ Automator can do precisely that. It can easily take over some standardized processes so that you can spend more time taking care of other tasks. But allow us to illustrate how exactly this works with a small example. In our office, we have mugs that explain in an abstract and easy-to-understand way how the Automator works. (Side note: Unfortunately, the Automator cannot actually help us with our morning coffees… not yet at least!)
Posted on April 21, 2021
Do you know where Kiribati is? Most of us didn’t before we heard about stranded seafarers in Hamburg, Germany, who are from the island republic along the equator.
Being stranded in a metropolis of millions of people sounds a little strange at first, but these seafarers earn their living through shipping. When the corona pandemic began, they were no longer allowed to leave their ship for safety reasons. After nine months on board their ship, they were finally allowed to step foot on land. But instead of being flown home, Kiribati refused their entry due to the pandemic, and they ended up stranded in Hamburg.
Posted on March 22, 2021
On March 10, 2021, the USFDA announced that they would begin to enforce the new eCTD validation checks on September 15, 2021. From then on, the USFDA could start rejecting submissions that do not conform with the Technical Rejection Criteria (TRC) formulated in the new eCTD validation criteria (v3.9) with error codes 1734, 1735, 1736, and 1789 for study data. In addition, the eCTD validation criteria for both CBER and CDER are starting to differ significantly from each other.
This entry was posted in Regulatory Affairs News.
Posted on February 15, 2021
Finger on the pulse: LORENZ brings innovation to the Regulatory Affairs world
The continuous technical advances in the digital world also bring new challenges. Efficient data and process management and the integration of process steps are becoming ever more complex. Over the past three decades, LORENZ has continuously taken the latest technical advances and trends and applied them to the specialized world of regulatory affairs.
Posted on January 18, 2021
A passion for learning: part of the LORENZ DNA
In 2008, our president Wolfgang Witzel was appointed visiting lecturer at the University of Bonn, working with the German Society for Regulatory Affairs (DGRA) to create a master's degree program in Regulatory Affairs. This graduate-level course draws lecturers from institutions, government agencies, pharmaceutical companies and consulting firms. To this day, Witzel remains passionate about the program and still heads a course module, passing on his know-how to a new generation of regulatory affairs experts.
Posted on December 16, 2020
We wish all of our customers and partners a very Happy New Year!
The year 2020 was full of changes and challenges, but it also created many new opportunities. The pandemic changed the way we work at LORENZ, yet also proved how quickly we could adapt to the situation. As this eventful year comes to an end, take a journey with us to review all that happened at LORENZ.