Regulatory authorities such as the Turkish Medicines and Medical Devices Agency (TİTCK), the U.S. Food and Drug Administration (US FDA) and the European Medicines Agency (EMA) have published a series of announcements regarding the three-step information and documentation requirements, as well as the timelines for submission of related activities for chemical drug substances and biological products.
Within our WMINOLAB Innovation Laboratories, we carry out nitrosamine determination studies with a strong infrastructure of advanced technological instruments and a highly qualified team of device specialists and academic experts with long-standing R&D experience. Our approach is built on high quality, reliability and continuity of service.
With our expert staff and state-of-the-art equipment, we offer support in many areas including consultancy, risk assessment, analytical method validation, verification and quality testing.
To benefit from our analytical services and obtain more detailed information, you can contact us through our website or via e-mail at wminolab@worldmedicine.com.tr.
