ABOUT US

Novagenix Bioanalytical Pharmaceutical R&D was established as a Bioavailability/Bioequivalence (BA/BE) center in response to the need for internationally accredited organizations in our country that determine and certify the efficacy and therefore the quality of pharmaceuticals.

Novagenix operates in areas such as bioavailability/bioequivalence studies, generic drug R&D, formulation development, analytical method development, CTD preparation, herbal product analysis, presence/absence analysis, generic product pharmaceutical R&D, subcontract production, and medical device manufacturing.

While providing all these services, Novagenix operates within the framework of:

1. ICH-GCP, Helsinki Declaration, EU-CT & GCP Directives
2. ILU (Good Laboratory Practices)
3. ISO 9001 Quality Management System
4. ISO/IEC 17025 certification
5. ISO/IEC 13485 certification

In this context, Novagenix also conducts its clinical studies in clinics with GCP certification (Gaziantep University Faculty of Medicine FARMAGEN Clinical Research Center and Erciyes University Faculty of Medicine, Hakan Çetinsaya GCP Center).

Novagenix maintains the quality and standards of its laboratory studies in accordance with the regulations of the Republic of Turkey. This has been substantiated by the GCP certificate issued by the Ministry of Health. In addition, in January 2003, it received the "OECD-GLP Conformity Certificate" from MiS Group, an international auditing organization, and the "GLP Conformity Certificate" within the framework of OECD and EU principles.

Our company is a pioneer and the first in our country in the field of bioequivalence. Our reports are prepared in ICH E-3 format and have international validity. Our work has been approved by authorities in many countries, primarily Germany, and today our sponsors' medicines are available in many countries around the world.

Address

Novagenix Biyoanalitik İlaç Ar-Ge Merk. San. Tic. A.Ş.
Balıkhisar Mah. Özal Bul. Novagenix Blok No: 395 06750 Akyurt / Ankara
TÜRKİYE

Contact

Phone : +90 (312) 398 10 81 
Fax : +90 (312) 398 07 18

E-mail

info@novagenix.com 

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