NOVAGENIX BIOANALYTIC DRUG R&D CENTER

Ankara , Turkey

Novagenix Drug Reaserch and Development Center is a bioavailability and bioequivalence laboratory which has been established to supply the clinical trials (including bioequivalency studies) requirements of pharmaceutical companies.

Our center is the first in our country and because of the specification and workspace of the charter members, there is a public sector charachteristic of the center too.      

Novagenix Drug Reaserch and Development Center has been established by ;

1.    Turkish Pharmacists Foundation

2.    Turkey Technology Development Foundation

3.    All Pharmacists Manufacturing Ensurance Distribution Cooperative Union

4.     Bio Inova Life Sciences International

5.     Pharmacy Device Corporation

Its building, which is in Esenboğa Yolu, has 9280 m2 land and 3200 m2 closed area and has been designed speacially. It has been opened on 30.01.2000.

Scope of Novagenix is conducting the bioavailability and bioequivalence studies; to do clinical trials to reach the required data; to complete the  analysis of the biological matrices that is obtained at the end of the clinical trials with correct and fast methods; to convert the obtained data to statistical information according to current national and international bioequivalence studies’ requirements. While performing these services, Novagenix acts on;

1.      Good Clinic Practices (GCP)

2.      Good Laboratory Practices (GLP)

3.      ISO 9000 Quality System

Clinical studies are set in clinics certificated with “Good Clinic Practices Certificate”. Novagenix has been certificated by Turkish Republic Ministry of Health with “Good Laboratory Practices Certificate” . In addition, Novagenix has been  audited by MIS Group which is an international audit agency since the mid 2002. On January 2003 Novagenix has reached an acceptable status of GLP compliance “OECD-GLP Compliance”.

Novagenix, has high technology such as continuous airconditioner systems, uninterrupted power supply, electronic back-up system, local area network, a generator automatically kicks in and maintains a constant flow of power to each unit, subunits designed for highly specific usage in laboratory.

The devices used in Novagenix as follows:

·         High Performance Liquid Chromatography systems (HPLC)

·         Gas Chromatography Mass Spectrometry systems (GC-MS)

·         Liquid Chromatography Tandem Mass Spectrometry    systems(LC/MS-MS)

·         Refrigerated Centrifuges and Ultra Centrifuges Systems

·         -70°C deep freezers

Novgenix is currently has a lot of bioequivalence studies’ projects with most of national pharmaceutical companies.

Because of the increment on the number of our projects, we are continually optimizing the quantitiy of our qualified personnel. If necessary we take consultancy services from different specialists.

Novagenix is the first and the leader in Turkey in terms of the bioavailability and bioequivalence studies. In addition Novagenix is training the personnel who are willing to make the progress in the research and development area.