Quality Assurance

Quality Management

SMO-Pharmina is granted ISO 9001:2015 by the international certification authority TÜV SÜD, and annually undergoes audit by the same authority.
Our Quality management system aims to manage every component of the workflow optimally and achieve predetermined results that are targeted at the Sponsor’s and other interested parties’ requirements and expectations. 
SMO-Pharmina guarantees data reliability and accuracy through integrity, quality control, internal auditing and training.

Audit History

Over the course of 11 years, the sites participating in clinical trials managed by SMO-Pharmina have undergone more than 130 audits. According to the reports of Sponsors or CRO auditors, the centers did not reveal critical or major deviations. Two centers have undergone FDA inspections and no Form 483 was issued. 
SMO-Pharmina is inspected annually by ISO international auditors and contractor CROs.