Clinical Research Quality

Proven by over 100 audits conducted by customers and third parties,
all with positive conclusions and stating GCP compliance.

 

14 GCP inspections performed by EU regulatory authorities from Austria (3), EMA (1), France (2), Germany (3), The Netherlands (1) and Romania (4). Out of all the inspections, 9 were performed in Romania and 5 in Moldavia. All inspections concluded with GCP compliance.

 

In November 2013, one of our clinical sites in Moldavia was inspected by the FDA. The inspection concluded without FDA Form 483!

 

In September 2014, our own clinical research facility located in Cumparatura, Romania was certified ISO 9001:2008.

 

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