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