Internal audits : evaluation of the quality, preparation and training linked to inspections and certifications conducted by the Health Auth. and the Notified Bodies.

External audits of subtractors, suppliers of API according to GPX (GMP, GMD,

Assesment and implementation with the ISO 9001: 2008, dec 2015 and ISO 13485 : 2003 norms.

Assesment and implementation of the Quality Management System (QMS).

Analyzis and risk management plan.