Audit of Contract Research Organizations to estimate their qualification and operations’ control.
Audit of clinical trial (TMF maintenance, clinical sites, study documents, plans and their execution, SOP compliance, data quality, pharmacovigilance, and third parties)
Every single audit terminates with the Corrective Action and Preventative Action

Audit of outsource organizations to estimate their qualification and operations’ control and regulatory and Sponsor’s requirements’ compliance.
Audit of representative offices to render permanent pharmacovigilance and estimate regulatory and Head Office requirements’ compliance.
Audit of Registration Certificate to estimate regulatory and Quality Management system compliance

Audit of depots and distributors to estimate regulatory and Sponsor’s requirements’ compliance.
Every single audit terminates with the Corrective Action And Preventative Action.

Audit of manufacturing plants to estimate quality management, personnel management, facilities, documentation, manufacturing process, contract activities, reclamations and regulatory compliance.
Every single audit terminates with the Corrective Action And Preventative Action.

Audit of local and central bioanalytical laboratories to estimate regulatory and Sponsor’s requirements’ compliance. 
Every single audit terminates with the Corrective Action And Preventative Action

Quality management system audit under ISO 9001:2015; self-developed systems are also welcomed. During the audit we estimate the system’s efficiency, key processes, personnel and paperflow to confirm its requirements’ compliance and quality. 
Every single audit terminates with the Corrective Action And Preventative Action.

Delivering assistance to regulatory inspections and audits to demonstrate good compliance and successful results.