Clinical Unit

The fully equipped clinical facility with 6 saloons and internal emergency care unit is complying with the GCP guidelines.
Highly experienced and well trained physicians are taking care of the wellness and safety of our volunteers and assure the credibility, liability and trueness of the clinical trials data.
We are close collaborating with the local ICU, hospitals and certified clinical laboratories.

Bioanalytical facility

Temperature controlled area includes two laboratories – sample preparation and LC MS analysis-, an access controlled room for deep freezers etc.
The well trained analytical investigators expertise includes: method development & validation, biological samples analysis and analytical data management according to GLP guidelines.
All equipments are qualified and validated periodically.

Quality Assurance

Our QA unit assures that

each phase of the

bioequivalence trials are performed according to GCP & GLP guidelines, study protocols, internal and Sponsor's SOPs and relevant regulatory requirements.

Data obtained during the trials are validated through a well organized monitoring system with highly trained internal study monitor. This unit is working independently from the study staff.

PK & Statistics

Our very experienced PK and statistics staff assures the perfect study design for your products through: protocol and CRF design. A well designed protocol means 50% chance to good results.
PK analysis and biostatistics are performed with validated softwares, safety data are immediatelly reported to the Sponsor and final reports are signed off on time according to ICH E3 topic .