Novagenix Bioanalytical Drug R&D Center has been established as a Bioavailability / Bioequivalence (BY / BE) center as a result of the need for internationally accredited organizations that determine and certify the effectiveness and hence quality of the drug in our country. In addition to bioavailability / bioequivalence studies, we have also other service areas such as generic drug R&D, formulation development, analytical method development, CTD preparation, herbal product analysis, presence-absence analysis, chemical cosmetic packaging, food supplement production, medical device production.
While Novagenix performs all these services with the guidances and the directions of:
1. ICH-GCP, Declaration of Helsinki, EU-CT & GCP Directives
2. GLP (Good Laboratory Practices)
3. ISO 9001 Quality Management System
4.ISO / IEC 17025 certification
5. ISO / IEC 13485 certification.
In this context, Novagenix conducts its clinical studies in clinics that have GCP certificate (Erciyes University Faculty of Medicine, Hakan Çetinsaya GCP Center and Gaziantep University Faculty of Medicine FARMAGEN Clinical Research Center).
Novagenix meets the quality and standard of laboratory studies with the IGLP certificate given by the Republic of Turkey, Ministry of Health. In addition, in January 2003, "OECD-GLP Conformity Certificate" from MiS Group, an international auditing organization; It has received the "GLP Certificate of Conformity" within the scope of OECD and EU principles.
Our company is the first and the pioneer in our country in the field of bioequivalence. Our reports have international validity and have been approved by the authorities of many European Union countries, and today the drugs of our sponsors can be reached in the European Union countries..