No more paper submissions required for China NMPA
Posted on January 11, 2023
The China National Medical Products Administration (NMPA) have announced specific requirements regarding the implementation of electronic submissions of application materials for drug registration applications. With this, they plan to optimize the business environment, reduce the burden on enterprises, and improve the efficiency of drug review and approval.
This entry was posted in Regulatory Affairs News.
2022 in a blink of an eye – take a look with us!
Posted on December 20, 2022
Another year has flown past in a blink of an eye, and we want to look back at what has happened – do you want to join us on the trip down memory lane?
This entry was posted in LORENZ News.
LORENZ Converge - The first on-site conference after a two-year break
Posted on November 23, 2022
After a two-year hiatus from holding on-site conferences due to Covid-19, we were finally able to hold the first LORENZ Converge, a successor event to the renowned userBridge and LORENZLink conferences. It was a pleasure to see old acquaintances as well as many new faces! In the picturesque city of Brussels, participants came together to learn about the latest developments in the regulatory affairs sector, to socialize and connect with peers from around the globe, and meet members of the LORENZ team to enhance their product knowledge. If you weren’t able to join us, we’ve put together this short summary of the highlights:
This entry was posted in LORENZ Events.
The 22.2 releases of docuBridge, drugTrack, and eValidator are available!
Posted on October 31, 2022
Release Highlights:
What's new in docuBridge? The review process has been made more collaborative with the option to reply to notes and update statuses on notes in the Submission Workbench and webAccess Submission Workbench. Many new features await you in the webAccess content viewer, including text search, thumbnails, and office files support. A newly supported toolbar has been introduced in the webAccess Explorer Document Viewer which genables direct access to functions that the user is permitted to execute on a document. Click here to read more about these highlights: What's new in docuBridge 22.2?
This entry was posted in LORENZ Solutions and Services.
Sneak peek at our upcoming 22.2 releases
Posted on October 25, 2022
Sneak peek at the docuBridge 22.2 release:
This entry was posted in LORENZ Solutions and Services.
The next chapter in submission management modernization
Posted on July 29, 2022
Transformative changes related to submission management has become a popular discussion in many global forums over the past few years. This has primarily been fuelled on by the pandemic and the realization that modernization in regulatory practices and frameworks is vital to keep up with the needs of tomorrow.
Drug submissions continue to shift towards standardized formats and increase in volume, complexity. We have seen an evolution from uncontrolled paper to a broader global use of electronic Common Technical Document (eCTD) over the past years.
This entry was posted in LORENZ Events, Regulatory Affairs News.
Join us at our on-site user conference LORENZ Converge in Brussels, Belgium!
Posted on July 15, 2022
Since the Covid pandemic started we have been longing for this moment and can’t wait for our on-site conference to take place and finally meet you all in person once again. This year’s LORENZ Converge, our successor of userBridge and LORENZLink, will take place September 13-14 in Brussels, Belgium.
This entry was posted in LORENZ Events.
LORENZ Connect 2022: Valuable RA insights for more than 380 attendees in 32 countries!
Posted on May 23, 2022
Our third LORENZ Connect conference has come to an end. We would like to thank all of our speakers for the time and effort in preparing and giving their presentations, as well as everybody who tuned in to the event.
This entry was posted in LORENZ Events.