Staying up to date on regulatory issues and official procedures is key when developing Advanced Therapies. Gene therapy, as well as cell therapy and tissue engineering, represent groundbreaking techniques in health care and clinical research industries.
The Advanced therapy medicinal products (ATMPs) encompasses an innovative and heterogeneous group of products. The source of the raw Materia, the manufacturing process, the designs of the clinical trials, the pharmacovigilance, the authorization process… they all have a complex diversity. In addition, if ATMPs contain genetically modified organisms (GMO), the legislation on the deliberate release of the GMO in the environment must be applied.
Sermes CRO’s qualified team has achieved outstanding results when dealing with ATMPs, as we have taken part in the clinical development and authorization process of the first Advance Therapy Medicinal Product authorization in Spain (that took place in 2019).