Our QSE policy

Customer satisfaction is the key to Simafex’s development and sustainability. Simafex managed to develop  constructive and long-term relations with all its partners: regulatory authorities, local residents, suppliers and clients. Simafex, as a responsible  (accountable  citizen) corporation,  combines performance and sustainable development by complying with high quality, safety and environmental standards.

To achieve such goals requires a strong company culture in terms of rick anticipation and prevention. Simafex commits itself to a continuous development process aiming at promoting the individual responsibility of each staff member. Our policies include an active regulatory intelligence, regular internal audits supported by audits from both Guerbet and our customers.

Thanks to the close collaboration with our parent company, Guerbet, and with other international partners, we have developed a pharmaceutical culture in line with the full range of international quality requirements (ICH Q7A, Part II of the European Guide Lines). Simafex has been successfully inspected by the FDA in 2011 and 2013. ANSM (the French health authority) renewed the site GMP certification further to their last audit in 2014. Simafex has been accredited with the Japanese authorities since 2009 for the commercialization of an injectable API.