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.
Gunilla Ekström, VP Project Management at Gesynta Pharma, says:
“RegSmart has been a valuable partner for us in clarifying the regulatory pathway for our development programs. Their combination of scientific understanding and regulatory expertise has supported us in making decisions at critical stages. This guidance has provided both clarity and confidence as we move forward with our clinical studies for vipoglanstat, a novel non-hormonal treatment with the potential to offer much-needed relief to endometriosis patients.”
Marie Gårdmark, CEO at RegSmart Life Science, adds:
“Gesynta is developing highly innovative treatments in an area where patients really need new options. Our role has been to support them in navigating the regulatory landscape, from early development into clinical phases. By combining our expertise in regulatory science with Gesynta’s cutting-edge research, we can help ensure that promising therapies reach patients as efficiently as possible.”