The company was founded by Erik Steffensen in 2023. He is a former Vice President at Novo Nordisk and has 25 years of industry experience from various specialist and leadership positions. Erik holds a master’s degree in chemical engineering and biotechnology from Technical University of Denmark (DTU) in addition to a diploma in Business Administration from Copenhagen Business School (CBS). Erik has been working in Product & Process Development, Manufacturing, and Quality and has in-depth experience with both drug substance, drug product, medical devices, and combination products.  

Throughout his career Erik has been involved in numerous development projects within small molecules, biologics, and advanced therapy medicinal products. He has domain expertise within drug and device development covering Target Product Profile, lead candidate selection, clinical trials, product & process development, manufacturing process design, scale-up, process validation, technology transfer and regulatory submission. 

Erik has many years of experience within biopharmaceutical and device manufacturing and has a proven track record of increasing the productivity of the manufacturing processes by combining lean tools and domain expertise to make simplified processes which are GMP compliant and ready for digitalisation. He has experience preparing supply chain and manufacturing strategies involving suppliers and Contract Manufacturing Organisations (CMOs). Furthermore, he has been a Qualified Person (QP) with broad responsibility for quality and compliance across manufacturing sites.  

Erik has extensive experience interacting with health authorities. He has been involved in preparing regulatory strategies and has been writing and reviewing hundreds of regulatory documents and the underlying scientific reports. Furthermore, he has participated in more than 100 GMP inspections of which around 30 have been by US FDA.