Certification was granted by the Federal Agency for Medicines and Health Products (FAMHP) in Belgium.
The Mont-St-Guibert production facilities are used in the manufacture and testing of Cardio3 BioSciences’ C3BS-CQR-1, a regenerative therapy currently in development for the treatment of heart failure, the company said.
C3BS CEO Christian Homsy said: "Gaining GMP certification from the health authorities is also a key step for Cardio3 BioSciences ahead of our planned Phase III trial for C3BS-CQR-1, a product we believe offers a potentially revolutionary new approach for the treatment of heart failure, one of the world’s most significant unmet medical needs."