Latest updates about Novagenix
We have successfully passed the audits of many authorities, including EMA-BfArM.
Novagenix is 26 years old.
We said Happy New Year with our new collaborations and initiatives!
Our pipetting robot has started working at Novagenix!
Bioequivalence / Bioavailability
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.
Novagenix plays an active role in the planning, execution, and reporting of phase I-III studies conducted to obtain bioavailability / bioequivalence and pharmacokinetic (PK)/pharmacodynamic (PD) data, which support the research and development efforts of the pharmaceutical industry.
We offer customized bioanalytical solutions that deliver reliable and reproducible results, even in the most complex biological matrices.
• Full compliance with ICH M10, FDA, and EMA guidelines
• Expertise in challenging molecules, including endogenous compounds, chiral molecules, prodrugs, and photosensitive analytes
• Rapid method initiation with optimized workflows to accelerate project timelines
• Method development and validation on advanced LC-MS/MS platforms
Services provided for BE/BA include:
• Study design and determination of sample size
• Preparation of raw data for statistical analysis,
• Calculation of pharmacokinetic parameters and evaluation of BA/BE criteria
• Reporting subject-based concentration–time data in tabular and graphical formats together with statistical analysis results,
Our Reporting Services for Bioavailability / Bioequivalence studies:
• Reporting of participant-based data, tables and graphics together with statistical analysis results
• Preparation of the Clinical Study Report in accordance with the ICH E3 format,
• Sharing Clinical Study Report with the sponsor in soft copy and electronic formats,
• Providing the necessary support to the sponsor in case of questions from regulatory authorities following the marketing authorization application.
Novagenix provides its entire data infrastructure independently, operating 24/7 with distributed cluster virtual server systems.
As a member of the Turkish Cybersecurity Cluster and Communication Technologies Cluster, it possesses server systems backed up using a three-location policy and its own local cloud infrastructure.
Generic Product Pharmaceutical R&D
Novagenix determines, develops, and validates the necessary analytical methods for the physical and chemical analysis of the formulations it develops. It supports safety, efficacy, and quality continuity through studies conducted in accordance with international guidelines (Turkish Pharmacopoeia, European Pharmacopoeia, American Pharmacopoeia, and British Pharmacopoeia, etc.) and the regulations and guidelines of the Turkish Ministry of Health, ICH Pharmaceutical Development Q8(R2).
The Xevo G2-XS QTof Quadrupole Time-of-Flight Mass Spectrometry LC/MS and GC/MS instrument enables measurements with unparalleled speed and sensitivity for quantitative and qualitative analyses. It offers the lowest detection limits achievable by a high-resolution LC/MS and GC/MS instrument. It can be used in proteomic and metabolomic studies.
• Production of food supplement products (ISO 22000 and GMP)
• Production of medical device products
• Formulation development and laboratory production of food supplement products
• Preparation and consultancy for Ministry of Agriculture licensing applications
• Consultancy for medical device applications and file preparation
To date, unique methods for the analysis of 314 molecules have been developed and validated; a list of these methods can be found here.
