Regulatory and Quality Assurance

The Regulatory and Quality Assurance team at Asklepios BioPharmaceutical is responsible for ensuring compliance with regulatory standards and quality guidelines throughout the development and manufacturing processes of AAV gene therapies. This team collaborates with regulatory agencies to oversee the approval of clinical trials, while implementing Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) to maintain the highest quality and safety standards for genetic therapies.