Heta Karvinen has worked at Medfiles since 2013. She has over 13 years of experience from pharmaceutical development, dossiers for marketing applications and post-approval changes. Before joining Medfiles, Heta was involved in drug product and drug substance development in pharmaceutical industry. She has experience from planning pharmaceutical and chemical studies needed for global marketing authorisation applications and guidelines steering the development. At Medfiles Heta has worked as senior pharmaceutical chemical expert utilizing her experience in versatile drug development projects and taking care also for quality dossiers for human and veterinary products, post-approval variation applications and studies supporting these. She has also experience from active substance documentation at EU and US. Heta started leading the pharma regulatory services in February 2022.