Versantis is now in the listing of SME companies and on the EMA’s website (reference number C/498/15/01). This is the first regulatory achievement of Versantis that comes with significant incentives namely administrative and procedural assistance from the SME office, fee reductions for procedures including scientific advice, fee exemptions for certain administrative services, assistance with translations of the product information documents, and waiver of the MedDra licensing fee.
Positive in vivo efficacy and safety results pave the way for the regulatory preclinical studies.
Versantis successfully reaches its R&D targets set for 2015. Versantis freezes the formulation of its first product, VS-01, a life-saving solution for patients with acute liver disease. The team manages to set-up a scalable manufacturing process, complete the in vivo proof of efficacy in a rat model of acute liver failure, and assess the in vivo proof of safety in a larger animal model (pigs).
Versantis congratulates to all team members for these achievements and acknowledge them for their hard work and invaluable commitment!