Foundations and official institutions
Foundations, universities and other training centers
Regulatory support of scientific advice before AEMPS.
CIEMAT
Implementation of GMP regulations in the Gene Therapy Unit. GMP certificate issued by AEMPS.
Fundación INBIOMED
Advising on the implementation of GMP regulations in the Cytometry Platform for the analysis and control of Advanced Therapy Medicinal Products (ATMPs). GMP certificate issued by AEMPS.
Fundación Medina
Feasibility study for the construction and GMP certification of the facilities for the manufacturing of Gene Therapy medicines.
Centro Nacional de Investigaciones Oncológicas (CNIO)
- Scientific advice on AEMPS.
- Design of the regulatory path for the development of an Advanced Therapy Medicinal Product (ATMP).
Universidad San Pablo
IMMA- Fundation:
- Implementation of GMP regulations in the Cell Therapy Unit.
- Scientific advice on AEMPS: advice on the design of the clinical trial, pre-clinical and clinical studies, and design of the quality module for the preparation of an IMPD.
Centro de investigación biomédica Navarrabiomed (NVB)
Complejo Hospitalario de Navarra (CHN) y Centro de investigación biomédica Navarrabiomed (NVB):
- Scientific advice on AEMPS: design of the clinical trial, pre-clinical studies and design of manufacturing/quality module for immunotherapy with SARS-CoV-2 T-lymphocytes.
Centro de investigación biomédica Navarrabiomed (NVB)
- Implementation of GMP regulations in the Cell Therapy Unit for the manufacturing of ATMPs.
