In January, Aurevia was established from the merger of five European companies within clinical laboratory quality assessment, regulatory affairs, and clinical research. Now, Scandinavian CRO (SCRO) and QAdvis, clinical research and regulatory affairs experts in Sweden, will soon be fully integrated into Aurevia.
Scandinavian CRO is a contract research organisation (CRO) with broad experience in the clinical research of pharmaceuticals, medical devices, and IVDs, and a strong legacy of expertise that values close collaboration with each other and its customers.
QAdvis specializes in quality assurance and regulatory affairs (QARA) services for medical and in vitro diagnostic (IVD) devices. It has a strong position in the Swedish market and connections to national and EU regulatory bodies and committees.
– “We all share the same passion for quality, dedication, and taking pride and joy in our work,” say Ulrika Hammarström, the Founder and CEO of SCRO and now Head of the CRO business at Aurevia. “By joining forces, we will have an even greater opportunity to advance healthcare, and ultimately, to improve patients’ lives.”
Innovation Meets Regulation
As medtech and pharma race forward with AI, digital health, and new treatments, regulatory demands are growing too.
“The regulatory landscape has shifted a lot, especially with the introduction of European Medical Device Regulation (MDR) and In vitro Diagnostic Devices Regulation (IVDR). Understanding these regulations and changing interpretations can be a challenge for medtech companies,” says Anna-Karin Alm, QAdvis CEO and now Head of QARA at Aurevia. “Medtech companies need current, accurate, up-to-date guidance that gives them a roadmap and leads them on the right path.”
In life sciences, regulatory compliance and demonstrating efficacy and safety are vital throughout the product lifecycle from early development to clinical research, market access and post-market surveillance.
“When QARA and CRO experts move under one roof, we can support clients throughout their full product development lifecycle with comprehensive, agile solutions,” says Ulrika Hammarström, Head of CRO at Aurevia.
A People Business
With teams in Sweden, Poland, Germany, and Finland, Aurevia builds on the legacy of QAdvis and SCRO by strengthening partnerships with the Swedish industry, healthcare sector, and academia.
– “We can attract consultants who are passionate about being thought leaders. They engage with industry networks, understand evolving regulations, and contribute to developing standards and guidance. With them, we can stay at the forefront,” says Anna-Karin Alm.
– “We are a people business,” concludes Ulrika Hammarström and continues: “Together with like-minded professionals we are now creating a solid platform for future growth, not only for us, but for our customers.”
Read the full-article in Swedish at Dagensindustri.se
