Calliditas Therapeutics Expands Globally with D365

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The fast-growing biotech company Calliditas Therapeutics modernizes for a global market. The company future-proofs the sales and supply chain of pharmaceuticals through Microsoft Dynamics 365 in a successful collaboration with Implema. With the new business system, Calliditas is equipped to meet extensive requirements in the American pharmaceutical market.
Companies
Calliditas Therapeutics
Business Systems
Microsoft Dynamics 365
Sector
Life Science

Calliditas Therapeutics - Microsoft Dynamics 365

Calliditas Therapeutics was founded in 2004, as a small pharmaceutical company with research in and development and manufacture of so-called orphan drugs. These are advanced drugs intended for life-threatening or very serious diseases. Also for diseases that are rare with a relatively small patient group.

Since 2018, Calliditas has been a listed company on the Stockholm Stock Exchange. Caliditas had approximately 25 employees until 2021, when the company entered the American market. The company was listed on the American stock exchange in 2020. In less than a year, it grew to approximately 80 people engaged in the business. With its application, and subsequent approval, with the US Food and Drugs Administration (FDA), new demands were placed on the company, which meant a system-technical change. Calliditas needed to modernize and harmonize its business system – and the implementation of a new business system needed to be fast.

”As a pharmaceutical company with responsibility for the entire supply chain in the USA, new demands were placed on us. Requirements that we could not meet with our previous financial system. We needed to rethink and think new and introduce a system with better support for our business. And this should not take too long to implement.” says Jan Hedenström, Finance Director Calliditas

Calliditas, the small development company on its way to becoming a larger marketing company, needed support in selecting, implementing, and adapting a new business system to the growing business. The challenges in the work existed on several levels; we supplemented, documented, and further developed the internal resources, expertise, and IT and finance processes. Despite external support, we coordinated the project between Sweden and the USA and drove it across different time zones. This required all involved parties to collaborate effectively.

We needed support from a company with experience in rapid decision-making processes, the right expertise and a good understanding of the requirements within life science. In order to succeed in getting a new business system in place within nine months, we also needed to be able to apply best practices around all new processes, so that the entire business could function globally from our go-live.” continues Jan

Calliditas and Implema – a Perfect Match

Calliditas chose Implema based on three main aspects. Firstly, their many years of experience from life science and the pharmaceutical industry. Then their good prior knowledge of the requirements for documentation and testing of systems. Finally, their well-developed internal processes that ensure and maintain the customer’s regulatory compliance. Implema also showed its strength through its way of working, Implema Way. They quickly implement a standard that they then build on and develop together with the customer based on the customer’s needs.

In addition to the system implementation, Calliditas also received the support they needed to develop, document and test their own IT processes. Implema effectively combined senior and junior expertise to ensure functionality with good quality.

Feel free to watch our entire customer case together with Calliditas Therapeutics from Implema Inspire 2021 in Stockholm. Hear both Tonny Kvant and Jan Hedenström talk about Calliditas’ path to a modern business system:

A Well-Thought-Out Project Plan and a Well-Coordinated Implementation

In February 2021, they started the collaboration with a limited time plan and budget. The new business system from Microsoft Dynamics 365 needs to be ready to go-live no later than the first of September. They established the project plan and carried out the preliminary study immediately for a quick project start. Thanks to the preliminary study, it became possible, among other things, to identify such requirements that form the basis for a URS (user requirement specification). Something that contributed to laying the foundation for a rudimentary prototype of the system adapted for the pharmaceutical industry. On June 1, they started the implementation with a test phase until Midsummer and then gradually continued to develop the prototype until the go-live date.

Good Collaboration from Day one – one of Several Important Success Factors

An important success factor for the project was the collaboration between Calliditas, Implema and other external parties. From day one, all parties strived for a fruitful and rewarding exchange of expertise and to work effectively towards a common goal.

To summarize the most important success factors, I would say that the team that was formed was one of the most important. Also Calliditas’ mindset, their experience and competence from both the pharmaceutical industry and from implementing systems were of great importance. It facilitated rapid decision-making processes and contributed to good cooperation across several areas. Then our way of working, Implema way, and our application of working with standards was a key factor in delivering against budget and within the time plan, clarifies Tonny Kvant, ERP Project Manager, Implema.

Thanks to good preparation, a well-developed project plan and good teamwork, Calliditas was ready with its go-live as early as August 25, 2021. In this way, they were able to test the system thoroughly before the quarterly financial statements in September, and today Calliditas is well equipped with processes for finance, logistics and IT in place. They now have the platform they need for the American market and to grow.

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