Registration and certification

GMP

 

The Salin-de-Giraud factory, which has been working in accordance with Good Manufacturing Practices since 1996, is regularly inspected by the French Medicines Safety Agency (ANSM) on account of its production of active ingredients.

Expertise within the M2i group includes drafting regulatory dossiers: this enables the authorities to validate products requiring authorisation such as pharmaceutical active ingredients. This expertise resulted in the establishment and/or modification of 5 active substance master files (ASMF) between 2013 and 2015.

                                                 

 
 

FDA

 

M2i has set up a quality action plan at the Salin-de-Giraud site aimed at extending its European Good Manufacturing Practices (GMP) accreditation to US Food & Drug Administration (FDA) certification by 2019.

EPA

 

The site is also auditable by the EPA (Environmental Protection Agency) on account of its production of pheromones for biological crop protection.

        

Reach

 

M2i is taking the steps necessary to comply with the REACH regulation of the European Union which includes product registration: this regulation takes precautionary measures to protect human health and the environment.