More than 99,98% of compliant batches every year: It is the result of the Quality excellence which drives all activities within the site. Beyond the compliance to the cGMP, cGDP, and current norms, every staff member in his/her daily job works to evaluate the risks and implement means to guarantee the quality of the product we supply.
For each product or service, a quality analysis is done to guarantee that actions are put in place at the highest quality level and for the good level of cost. Dialog with our customers (internal and external) allows us to improve continuously the quality of our products and services for the satisfaction of all.
Involved in the Full Service Site approach, the quality department also supports the approval of suppliers including those of active ingredients (audit, quality follow-up …).
Regulatory Affairs are managed by a dedicated team of experts, part of the site. We can propose you service offer for key regulatory matters for CMC (Chemistry Manufacturing Control part) such as stability studies, transfer files, variation files, file update…
The site is approved for cGMP and cGDP by France and by Russia.