It has a closed area of 3200 m2 on a land of 9280 m2 on Esenboğa road. The specially designed building was laid in 1998, which meet all the requirements of a bioanalytical laboratory, with continuous air conditioning and ventilation, electrical energy continuity, specially designed areas for the purpose of use in each laboratory sub-unit, and specially designed sections for the work of technical personnel. It was designed and built with a high technology infrastructure. The foundation date of our company is February 9, 1999.
The "Good Laboratory Practices" document, which is a requirement for the bioanalytical studies, was issued on January 28, 2000 as "DOCUMENT NO: 1" by Ministry of Health, Republic of Turkey. And begins its service on January 30, 2000.
In the last quarter of 2005, a new sub-unit was put into service for in-vitro dissolution studies, where in-vitro dissolution studies of pharmaceutical companies' products are analysed and reported.
In 2006, a second sub-unit was put into service for impurity analysis.
On the other hand, preparations for Phase II, III, and IV clinical studies, along with the compilation of the CTD (Common Technical Document) file and drug/herbal product/cosmetic analyses, have already begun.
As of May 11, 2012, the Turkish Pharmacists Foundation became the majority shareholder of Novagenix, and following a final capital adjustment on December 30, 2013, it acquired full ownership (100%) of the company.
Novagenix collaborates with many leading companies in Türkiye’s pharmaceutical industry. Our Bioequivalence (BE) Study Final Reports, prepared in compliance with ICH E3 guidelines, have been submitted to and approved by regulatory authorities in European Union countries. Today, our sponsors’ drugs are available throughout all EU member states.
Additionally, Novagenix has established the capability to conduct Bioavailability (BA) and Bioequivalence (BE) studies entirely locally (domestically), offering a more cost-effective alternative compared to other EU countries. Furthermore, Novagenix employs R&D personnel trained to contribute scientific and technological expertise, fostering the necessary knowledge base within Türkiye.
