Alvotech - Better Access. Better Lives.

How this biosimilar company is simplifying control management

Alvotech’s positive experience using Impero

At a glance

  • More than 800 employees
  • Operations in Iceland, Germany, India, Luxembourg, Malta, Switzerland, the UK and US
  • 200 controls, 70 of which are monthly
  • Alvotech purchased Impero in the lead-up to a dual-listing on Nasdaq stock market in the US and Nasdaq First North Growth market in Iceland

“After a detailed evaluation of possible systems, it was the unanimous decision of the team that Impero stood out from the crowd, and in our mind, ticked all the boxes.”

Alvotech facilities in Iceland
Photo credits: Alvotech

About Alvotech

With an operational HQ in Reykjavik, Iceland, and operations in Germany, India, Luxemburg, Malta, Switzerland, the UK and US, Alvotech is on a mission to set a new standard in biosimilars.

With a joint focus on R&D and manufacturing, Alvotech aims increase access to affordable biologics for patients with chronic diseases such as cancer, rheumatoid arthritis, osteoporosis and eye disease.

This mission seeks to improve patient lives and enhance the sustainability of global healthcare systems, by lowering the cost of vital treatment options.

As it set out to list the company on both NASDAQ First North Iceland and the main market in New York, Alvotech’s finance team turned to Impero to help improve its control management processes.

'We wanted to have a better overview of the health of our controls'

Director of Internal Controls & SOX Compliance, Pétur Bjornsson, says that a part of the project to enhance the control management was to change the work processes from the start-up company phase and take it to the next level.

“We had implemented critical controls, but we wanted to have a clearer overview of our Risk Control Matrix (“RCM”),” Pétur says.

“We needed a more streamlined method to monitor control execution and documentation, that in turn helps to enforce and maintain discipline.We wanted to improve the overall RCM process, and make it even easier to keep an inventory of our controls.”

“Each control performer/owner was expected to safeguard control evidence but even though the evidence was available, it was often time-consuming to locate.”

'At the time, we were not aware of platforms like Impero'

“It was clear that we needed to augment our control management system.

“At the time we were not aware of platforms like Impero. We were using spreadsheets and other relatively manual processes to manage the controls,” Pétur explains.

“When our external consultants introduced to us the possibility of implementing a control management solution, we were sold on the idea and started vendor sourcing to see which one was the best fit for Alvotech.”

Alvotech female employee working and looking through a microscope
Photo credits: Alvotech

'Impero stood out from the crowd and ticked all the boxes'

Pétur says that among the criteria on Alvotech’s wish list was a user-friendly interface, all the required system capabilities, a knowledgeable customer support team and continuous development of the system.

“We didn’t want a system that was complex and inaccessible to our control contributors, as that might take up too much of their time and potentially prevent them from using it,” Pétur says.

“After a detailed evaluation of possible systems, it was the unanimous decision of the team that Impero stood out from the crowd, and in our mind ticked all the boxes.”

'The implementation was smooth sailing'

“The implementation of Impero didn’t take long, and it was smooth sailing,” Pétur explains.

“We decided to implement our control program in stages, so we provided the Impero team with the necessary information in batches to be uploaded to the system.

“During the overall implementation, the team was extremely helpful, gave us good advice and was quick in getting the job done.”

'We finally have the visibility and overview we wanted'

Pétur says Impero’s system is very easy-to-use.

“Our control contributors have no complaints, and they feel the system is very accessible. It’s easy for them to attach the control evidence in the system, with drag and drop, and add comments in addition to the system notifications being very helpful,” he says.

“Because we now have all our RCM in one place along with the control evidence, we finally have the visibility and overview we wanted.

“One of the benefits of a system like Impero is the possibility of granting external auditors view access of everything, along with audit trails. It also makes in-house monitoring of the controls easier.”

Alvotech employees working in a lab
Photo credits: Alvotech

'Without it, we'd have to chase people for documents and spreadsheets'

Following its dual-listing on the NASDAQ’s main market in New York and First North in Iceland, Alvotech is seeing the additional benefit of having Impero.

“It’s often said from SOX perspective that if it wasn’t documented it wasn’t done.

“Impero is very helpful in this context, as we can document everything in addition to us having everything time-stamped, with a full audit trail and change logs,” Pétur says.

Post-listing, Pétur says Impero is delivering value for the ongoing demands of its certifications.

“As we planned to become a US-listed company, and fulfil all SOX requirements, it became even more important for us to track the health of our controls. It would be much more difficult to do this without a system like Impero,” he says.

Without it, we would have to chase people for documents and spreadsheets. All of this is really helpful – as it would be so time-consuming to do this manually.”

'Using Impero can save time'

When Pétur introduces Impero in-house, he always mentions that it’s a control management system that is user-friendly and by using it correctly, people could save time. “Using Impero should save time in the long run,” he always tells the teams.

“Even though people need to invest a few minutes each time to document the controls, it’s beneficial for them in the long run.

“We try to emphasize that if people do a proper job with the controls, at the end of the day, they save time.”

'Selecting a system like Impero is a no-brainer'

If there’s one piece of advice Pétur has for companies in a similar position it’s that “selecting a system like Impero is very useful.”

“It is so much easier just to do things right from the beginning.”

“You’re investing a lot of money preparing for listing, so why not use the opportunity to address the control management at the start so you can see the benefits sooner?”

Close up of woman eyes wearing protection glasses
Photo credits: Alvotech

Ready to see what Impero could do for you?

Ready to see what that would mean for your business?

Book a personalized demo to discover the ways you and your organization can simplify compliance today.