Bulgaria I
MHAT Hospital Evropa OOD, Sofia Private Hospital
Section for clinical trials for bioavailability and bioequivalence of medicinal products
Intensive care and anaesthesiology monitoring
Continuous cardiovascular and vital signs monitoring
First in Men studies feasible
Investigators team GCP-inspected by Spanish, French, Austrian, Bulgarian, South African Authorities
Hospital certified by Ministry of Health, Bulgaria
Stability data not required
30–60 days approval time
24 beds
Bulgaria II
Queen Giovanna, Sofia, University Hospital
GCP-inspected by French and Bulgarian Authorities
Stability data not required
30–60 days approval time
18 beds
Bulgaria III
Ascendent Center for Clinical Trials, Sofia, Private Hospital
Gynecological examinations including histology at site
Passed FDA inspection with “NAI” (no action indicated) in September 2017.
GCP-inspected by Bulgarian Authorities
Stability data not required
30–60 days approval time
12 beds