AEMPSAgencia Española de Medicamentos y Productos Sanitarios (Spanish)
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Cliantha Research's facilities have been audited by the AGES (Austrian regulatory agency), ANSM (French regulatory agency), AEMPS (Spanish regulatory agency), USFDA, MCC (South African regulatory agency), WHO and International companies.
On a regulatory level, the approval we have received from the AEMPS indicates that we have met the new stringent requirements that have been set in place by the recent adoption of the new clinical trial directive in the EU for cell product clinical trials.
Earlier this month, the Company conducted pre-submission meetings with the EMEA assigned rapporteur and co-rapporteur countries, namely the MPA (Medical Products Agency) of Sweden and the Spanish AEMPS (Agencia Espanola del Medicamento and Productos Sanitarios).