May 27, 1994 in the "Regulation on Assessment of Bioavailability and Bioequivalence of Pharmaceutical Preparations" in Turkey Following the publication in BA / BYU need to establish a research laboratory that has arisen.
Novagenix Bioanalytical Drug R&D Center is a laboratory established by the partnership of:
1. Turkish Pharmacists Foundation (TEV)
2. Technology Development Foundation of Turkey (TTGV)
3. S.S. All Pharmacists Production Supply Distribution Coop. Union (TEKB)
4. Bio-Innova Life Sciences International
5. EGAŞ Pharmacy Equipment Corp.
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, constructing for Phase II, Phase III, Phase IV clinical studies, preparation of the CTD license file, drug / herbal product / cosmetic analysis have been started.
As of May 11, 2012, the Turkish Pharmacists Foundation has become the biggest stakeholder by purchasing the majority share of Novagenix, and with the last capital arrangement made on December 30, 2013, the Turkish Pharmacists Foundation's share in our company became 100%.
Novagenix conducts joint studies with many distinguished companies of our domestic pharmaceutical industry. Our Bioequivalence Final Reports, prepared in ICH E3 format, have also been submitted to and approved by the authorities of the European Union countries. Today, the drugs of our sponsors are available all across the European Union member countries. Also Novagenix, completely built the constructing and executing the BA / BE studies locally and domestic with more cheap to the other EU countries. Novagenix also engaged the R&D personnel trained to provide the contribution and scientific/technological knowledge constitutes the necessary accumulation in Turkey.