Medace aids the Dutch start-up company InoCells to enter the European market with their infertility stem cell therapy. Their therapy has already been approved outside Europe and thanks to the company’s close collaboration with Medace, the European application to the European Medicine Agency (EMA) is also progressing smoothly.
In only 3 months, InoCells has gained the approval of the EMA to classify their product as somatic cell therapy medicinal product. Jessica Gerards, Quality Manager ATMP: ‘For InoCells we were confirmed by EMA that we needed to follow a specific GMP guideline on base of which we will build our quality system.
Professor Mohammad Mehdi Akhondi, Director at InoCells: ‘Navigating the regulatory approval process is time consuming & complicated for new therapies. InoCells and Medace have shown how experts can come together to smoothen this bumpy road.