Gradocell Advanth Clinical Services

Gradocell is a specialized contract research and consulting organization focused on the development and manufacture of Advanced Therapy Medicinal Products (ATMPs), including cell and gene therapies. The company provides comprehensive services ranging from regulatory affairs and quality assurance to the implementation of Good Manufacturing Practice (GMP) standards for clinical and commercial production. Gradocell supports academic institutions, hospitals, and biotech companies in navigating the complex regulatory landscape of the European Medicines Agency (EMA) and the Spanish Agency of Medicines and Medical Devices (AEMPS). Their expertise includes the design of cleanrooms, validation of manufacturing processes, and the management of clinical trials for innovative therapies.