Our bioanalytical laboratory combines global CRO standards with boutique service flexibility and advanced analytical technologies.
For the recent list of validated methods please click
Novagenix Bioanalytical Laboratory is a GCP-certified center specializing in conducting bioavailability (BA) and bioequivalence (BE) studies.
Our bioanalytical laboratory combines global CRO standards with boutique service flexibility and advanced analytical technologies.
For the recent list of validated methods please click
- 3 x SHIMADZU 8060
- 1 x SHIMADZU 8050
- 2 x SHIMADZU 8040
- WATERS Xevo TQ-S Micro
- WATERS Xevo TQD w/H-CLASS UPLC
- WATERS TQD w/H-CLASS UPLC
- WATERS TQD w/UPLC
- WATERS QUATRO MICRO API w/2695 HPLC
1 Andrew+ Pipetting Robot
High Capacity
Strong operational infrastructure for high-volume bioequivalence and clinical trials with an annual processing capacity of 100,000+ samples
Robotic Precision and Reproducibility
Sample preparation processes that minimize human error and ensure maximum reproducibility with the Andrew Alliance robotic pipetting system
Wide Method Portfolio
More than 310 validated and actively used bioanalytical methods developed and validated in accordance with current guidelines
Comprehensive and Integrated Solutions
A single-point service model encompassing small molecule bioanalysis with LC-MS/MS infrastructure and elemental analysis with ICP-MS
Regulation and Quality Assurance
Production of bioanalytical data compliant with FDA, EMA, and ICH M10 requirements; ready for inspection and licensing applications
Our laboratory plays an active role in routine bioequivalence studies as well as R&D projects conducted under the TÜBİTAK 1004 program; integrating innovative analytical approaches into regulated clinical processes.
• 1755 m2 laboratory area with controlled access via facial recognition and fingerprint
• Separate sample preparation rooms for each laboratory assistant
• Special rooms for light-sensitive molecules
• Reference material room with restricted access
• Fume hood for sample preparation and evaporator systems
• Weighing room with restricted access
• Deep freezer room with restricted access and continuous temperature monitoring at -20 ºC and -70 ºC
• Refrigerators and freezers with continuous temperature monitoring at +4 ºC and -20 ºC
• Chemical storage
• Glassware cleaning room
• Emergency power supply for all equipment
• Uninterruptible Power Supply (UPS) unit
• Scroll pumps, nitrogen generators
• Central smart air conditioning system
• Central wireless alarm temperature and humidity monitoring system