From Niche Development Company to Global Player
Calliditas Therapeutics was founded as a small pharmaceutical company focused on research, development, and manufacturing of so-called orphan drugs— advanced medications designed for rare and often life-threatening diseases.
The company is listed on both Nasdaq Stockholm and Nasdaq New York. From being a smaller company for a long time, the organization grew rapidly when establishment in the American market gained momentum. When the application to – and subsequently approval from – the US Food and Drug Administration (FDA) went through, entirely new requirements for system support and regulatory compliance were imposed.
“As a pharmaceutical company with responsibility for the entire supply chain in the U.S., entirely new demands were placed on us. Our previous system simply wasn’t sufficient. We needed to think differently and implement a business system with better support for our operations – and it couldn’t take too long”, explains Jan Hedenström, Finance Director, Calliditas Therapeutics.
The Need: A Global Business System — in Just Nine Months
When Calliditas prepared to scale up operations in the U.S., it became clear that a new business system was needed – a system that could handle complex regulatory requirements, enable efficient global processes, and be implemented quickly.
The challenges were many: limited internal resources, the need for new processes, and a project that would be executed across multiple time zones between Sweden and the U.S.
To meet these requirements, Calliditas chose to partner with Implema and implement Microsoft Dynamics 365 – a modern, cloud-based business system that creates full integration between finance, logistics, and sales.
“We needed support from a company with experience in rapid decision-making processes, the right expertise, and understanding of Life Science requirements. To succeed within nine months, we also had to work according to best practice and build a global platform from the start”, continues Hedenström.
Calliditas and Implema – a Perfect Match
When Calliditas chose Implema, it was based on three decisive factors:
- Years of experience in Life Science and the pharmaceutical industry
- Deep knowledge of documentation and testing requirements
- Well-developed internal processes for regulatory compliance
Implema also demonstrated the strength of its approach, Implema Way, where they implement quickly on standard and then build further together with the customer. In addition to the implementation itself, Calliditas also received support to develop, document, and test their own IT processes.
“For us, it was a combination of senior and junior expertise that made the difference. We got both quality and pace in the delivery”, says Hedenström.
A Well-Thought-Out Project Plan and Close Collaboration
The project began with a tight timeframe and budget. The goal was a go-live within nine months – with a new business system ready to handle both sales and supply chain. The feasibility study started immediately and formed the basis for a URS (User Requirement Specification) and an initial prototype adapted for the pharmaceutical industry. Implementation and testing began quickly, and development of the prototype continued step by step until go-live.
One of the biggest success factors was the collaboration between Calliditas, Implema, and external partners. All parties worked from day one toward a common goal – and with an open exchange of knowledge and experience.
“The team that was formed was crucial. Calliditas’ mindset, industry experience, and ability to make quick decisions contributed strongly. Our own approach, Implema Way, and focus on standard processes made it possible to maintain both timeline and budget”, explains Tonny Kvant, ERP Project Manager, Implema.
The Result: Ready for the American Market
Thanks to careful preparations, a thorough project plan, and strong teamwork, Calliditas went live well before an important quarterly closing – and could test-run the system live from day one.
Today, Calliditas has a platform that supports the business processes for finance, logistics, and IT – fully equipped for the American pharmaceutical market and for continued global expansion.
Feel free to watch our complete customer case together with Calliditas Therapeutics from a previous Implema Inspire in Stockholm. Hear Implema’s Tonny Kvant and Jan Hedenström tell about Calliditas’ journey to a modern business system:
