Because OnDosis’ products are classified as combination products, they must comply with regulatory requirements from both pharma and medtech. This creates a highly complex environment where clear guidance and regulatory expertise are essential.
Stina Wigren, COO at OnDosis, says:
“RegSmart has been crucial for OnDosis in navigating the complex regulations that exist at the intersection of medical devices and pharmaceuticals throughout our product development. Their professionalism and extensive knowledge have been invaluable, providing clarity and confidence in challenging situations. Beyond their expertise, the team’s warm and approachable personalities made the collaboration a true pleasure. We are very grateful for their support and cannot recommend them highly enough.”