The quality assurance system at the Novagenix Bioanalytical Drug R&D Center has been implemented since 2000. Our activities, which began under the scope of GLP, have continued under the scope of GCP since 2009 due to the content of our studies. An integrated quality system is in place that meets all requirements under GCP, ISO9001, and ISO17025. In addition to regular annual inspections conducted by national authorities, many Sponsors also conduct inspections at our center. Furthermore, study-based inspections are also carried out by foreign authorities. To guarantee data integrity from the receipt of study samples at Novagenix to the final study report, a Quality Assurance system compliant with national and international guidelines and regulations is implemented.

For recent certificates, please click here.

The quality assurance system at the Novagenix Bioanalytical Drug R&D Center has been implemented since 2000. Our activities, which began under the scope of GLP, have continued under the scope of GCP since 2009 due to the content of our studies. An integrated quality system is in place that meets all requirements under GCP, ISO9001, and ISO17025. In addition to regular annual inspections conducted by national authorities, many Sponsors also conduct inspections at our center. Furthermore, study-based inspections are also carried out by foreign authorities. To guarantee data integrity from the receipt of study samples at Novagenix to the final study report, a Quality Assurance system compliant with national and international guidelines and regulations is implemented.