Calliditas Therapeutics, a small pharmaceutical company focused on research, development, and manufacturing of so-called orphan drugs. These are advanced medicines intended for life-threatening or very serious diseases, as well as rare diseases with a relatively small patient population.
Since 2018, Calliditas has been a publicly listed company. In less than a year, it grew to about 80 people engaged in the business. With its application, and subsequent approval by the US Food and Drug Administration (FDA), new requirements were imposed on the company, necessitating a system technology transition.
“As a pharmaceutical company responsible for the entire supply chain in the USA, new demands were placed on us. Demands that our previous financial system could not meet. We needed to rethink and innovate, and implement a system that better supports our operations. And this could not take too long to implement,” explains Jan Hedenström, Finance Director at Calliditas.
Calliditas, the small development company on its way to becoming a larger market company, needed support in selecting, implementing, and customizing a new business system for its growing operations. The challenges in the work were at several levels; we complemented, 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 managed it across different time zones. This required all involved parties to collaborate effectively.
As a pharmaceutical company, responsible for rapid decision-making processes, the right expertise, and a good understanding of the requirements within life sciences. To successfully implement a new business system within nine months, we also needed to apply best practices for all new systems.
Calliditas and Implema – a Perfect Collaboration
Calliditas chose Implema based on three main aspects. Their many years of experience with life sciences and the pharmaceutical industry, their good knowledge of the requirements for documentation and testing of systems, and their well-developed internal processes that ensure delivery within budget and on schedule. Implema implements a standard quickly, which they then expand and develop together with the customer based on the customer’s needs.
In addition to the system implementation, Calliditas received support to ensure functionality with good quality.
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A well-thought-out project plan and good teamwork ensured that Calliditas was ready to go live on August 25, 2021. This allowed them to test the system in a live environment. They now have the platform they need for the American market and to grow.
From February 2018, Calliditas has been a publicly listed company. In less than a year, it grew to about 80 people engaged in the American market. The company was listed on the American stock exchange in 2020. With its application, in turn, approval by the US Food and Drug Administration (FDA) imposed new requirements on the company, necessitating a system technology transition. Calliditas needed to rethink and introduce a system with better support for their operations. And this could not take too long,” continues Jan.
A Great Collaboration from Day one – one of Several Key Success Factors
A good collaboration from day one – one of several key success factors
A key success factor for the project was the collaboration between Calliditas, Implema, and other external parties. All parties strived from day one for effective cooperation.
Thanks to a well-prepared project plan and good teamwork, Calliditas was ready to go live on August 25, 2021. This allowed them to test the system in a live environment. As a result, they now have the platform they need for the American market and to grow.
