Lorenz Blog

Dr. Franziska Menzel, the Head of Regulatory Affairs at our longstanding customer CO.DON AG and Matthias Schremser, Global Key Account Manager Industry and Agency at LORENZ, sat down together to talk about the experience of upgrading from LORENZ docuBridge ONE to FIVE.

Dr. Franziska Menzel has been with CO.DON AG since 2019 and Head of Regulatory Affairs there since February 2021. She has many years of professional experience in the Regulatory Affairs sector. In previous jobs, she had been using docuBridge for authorizations as early as 2017.

“In the end, everything worked out well with the submission and everyone was very happy that it could be compiled relatively easily and sent out so quickly”

Why did CO.DON decide on docuBridge ONE back in 2016?

Dr. Franziska Menzel: At the very beginning, our RA work was carried out by an external service provider. When it came to pan−European authorization, we wanted to become more independent. At that time, we weren’t clear about the entire authorization process, and everything in the ATMP area was completely new to us. We asked ourselves, how do we go about getting an authorization − and will we get one at all? At this point, we were only talking about one single approval, so we decided on the cost−effective docuBridge ONE variant. The most important thing at the time was to find a solution quickly.

Matthias Schremser: Before Dr. Menzel started at CO.DON, Dr. Jandke, Head of Regulatory Affairs and Senior Manager there, was our contact person. I worked with him a lot back then. Their service provider had already created some preliminary sequences using docuBridge, and had managed the entire compilation in the process. At that point, the decision was made at CO.DON to handle it all internally in the future.

It was important to CO.DON that a large submission was actually possible using docuBridge ONE, despite it being the smallest submission management solution from LORENZ. There was also the question of cost. Since there weren´t that many submissions, the token approach made sense. Also, having the possibility to add regional modules in the future was another important factor for them.

For Dr. Jandke it was also important that docuBridge ONE included practical eLearning modules. And of course another extremely important question was: What happens if they have a problem, since they still don´t have that much experience with docuBridge? What is the support from LORENZ like? Back then I explained that LORENZ support is always available for technical questions, and that we also offer separate live support sessions for content−related questions.

In the end, everything worked out well with the submission and everyone was very happy that it could be compiled relatively easily and sent out so quickly. There’s even a picture where everyone is sitting happily in front of a computer at 3:00 am, jubilant at the successful send−off. The actual authorization was issued within half a year, which was very important. Plus, I personally also learned a lot in the process. After that, the company continued to work with docuBridge ONE, and went on to purchase the Swiss module.

Why did you make the switch from docuBridge ONE to FIVE in 2020?

Dr. Franziska Menzel: At the beginning, because we were still a small team, everything worked fine with docuBridge ONE. Then in 2020, we had 3−4 very large submissions that included extensive document packages, and there was a lot of linking work involved in the submission. By then we had marketing authorizations in both the EU and Switzerland, so it became increasingly important to be able to divide up the work relating to submissions. Then Brexit and our third marketing authorization, for the UK, came along. That’s when it became clear that docuBridge ONE wasn´t going to work for us in the long run.

And that was basically the main reason: we already had three authorizations, plus several other large submissions that needed to be created in parallel.

I had previously worked at two other companies, and both had used docuBridge FIVE. So I was already familiar with the product, and was pleased with the decision to switch from docuBridge ONE to FIVE.

“It’s exactly when you run into a problem just ahead of a deadline, that it’s so vitally important to get fast support”

Why did CO.DON go for LORENZ once again?

Dr. Franziska Menzel: We never even discussed if another solution might come into consideration. We didn´t make any comparisons. I think it was clear to us from the very start that we would stay with LORENZ. Everything had always worked well, especially during the actual approval process. The service and support were great. And even afterwards, whenever we had questions, everything was always fine. It´s exactly when you run into a problem just ahead of a deadline, that it’s so vitally important to get fast support. We worked very well with the software. We were satisfied, so we didn´t even think about changing.

Also, our Account Manager responds super quickly. We never had to wait longer than two days. It’s easy and uncomplicated for us. We were − and are − quite simply satisfied.

How did the actual changeover process work?

Dr. Franziska Menzel: The changeover worked very well. The only problem with switching from ONE to FIVE was that the eSubmission codes were no longer set. And the variable file names were gone.

Matthias Schremser: In the configuration of docuBridge ONE, it´s possible to fill the “Sequence Description” attribute with information. This function had been used heavily. However, in the docuBridge FIVE configuration, the field isn’t included by default, so it had to be recreated, and the contents transferred afterwards. LORENZ took note of this, and we´re now also planning it into future migrations.

Dr. Franziska Menzel: That was a one−off effort, but otherwise there were no problems at all. The whole thing actually came off very well, and the two-day training session was effective and understandable. In total, the changeover process took us 3-4 months, in consultation with our IT. That was up to us, because we had to find a suitable timeframe.

“You barely notice the change from ONE to FIVE, except for the fact you’ve got some helpful additional features”

Was it an advantage that you already knew docuBridge ONE?

Dr. Franziska Menzel: Definitely. In the end, the only thing that was completely new to my colleagues was the Document Management System area, which is included in docuBridge FIVE but not available in ONE − I was already acquainted with this from my previous work with docuBridge FIVE. It was good that I was able to give others a bit of help, because there were in fact a few questions.

As far as the submission workbench is concerned, it´s great, and it was definitely helpful that we already knew the basics. You barely notice the change from ONE to FIVE, except for the fact you’ve got some helpful additional features, like the PIN on the desktop.

How satisfied are you with the new solution?

Dr. Franziska Menzel: Very satisfied. Last year, we got all of our submissions completed on a tightly staggered schedule. Without docuBridge FIVE, we simply couldn´t have done it. These days, we have fewer and fewer error messages, and we’re getting better at figuring out the reasons for them on our own. The more experience you get, the more intuitive it all becomes. We´re completely satisfied with LORENZ and docuBridge, and definitely don´t regret the changeover.

This entry was posted in LORENZ News, Regulatory Affairs News.