Audits & Certification (GxP, FDA, WHO, QP):

- Contact and communication with Authorities and State Drug Agency,

- Organization and conducting of internal self-inspection according GMP, GDP, GLP, FDA, ICH, WHO,

- Preparation and implementation of the CAPA plan with Risk Analysis,

- Support during external Audits and Inspections (from the authorities, customers, partners),

- Audit and qualification of Suppliers and Partners.