Technical Premises
Both production buildings are equipped with high-tech facilities to meet all regulatory requirements (GMP and GDP) for the processing and storage of Investigational Products, materials, documents, biological samples and IT systems.
CAGNES SUR MER
Pharmaceutical activities
(Authorisation n° 2022_301_1_2_10)
Dedicated to the Pharmaceutical activity, with a potential storage of 2000m3 at room temperature (+15°/+25°C), 4 cold rooms allowing storage between +2/+8°C, and freezing units for storage at -30°C and -80°C.
SAINT-PAUL-DE-VENCE
Biological activities
Located less than 2 minutes from the Cagnes-sur-Mer building dedicated to the production of biological sampling kits sand Biobanking, including storage units at room temperature (+15/+25°C), at +2/+8°Cand freezing units for storage at -30°C and -80°C.
The high-tech equipment at these two sites meets the highest regulatory requirements: the qualification of the climatic chambers is carried out according to the FD X15 140 documentation booklet and the validation of the IT systems complies with Appendix 11 of the GMP. Access to these areas is secure and controlled by a personalised badge system.
Each building has its own stand-alone generator to provide power in the event of a power outage. The stand-alone generators are tested monthly.
Secure and controlled access.
Both buildings are protected by a security system that detects any anomalies such as attempted intrusion, fire, power outage, temperature and humidity variations outside the thresholds defined by area (24/7). This system is connected to a surveillance company and allows immediate intervention by the on-call team.