Bio Analytical Services

The BA team at CEBIS has a strong experience in wide range of bio-analytical services including (Method development, assay validation, and sample analysis using modern LC/MS/MS equipment).

At CEBIS, we have the the capability to handle various types of extraction procedures like liquid-liquid extractions, solid-phase extractions and pre-column | post-column derivatization procedures. Our BA team has the complete and strong knowledge of the specific regulatory requirements of various international regulatory agencies.

Our team has good experience with a method data bank of over 200+ drug assays for multiple analytes and metabolites. As a Good Laboratory practice, the CEBIS team perform bio analysis in line with international regulatory requirements with constant check from In Process Quality Control Team.

Infrastructure

Our Bioanalytical lab is equipped with the following :

• 2 LC-MS/MS (SCIEX API 4500). And 2 new API 6500 are being added in the lab.
• 7,500 square-foot bio-analytical area.
• Independent Sample Separation / preparation Area.
• Solid Phase Extraction Systems (48 position SPE)
• Nitrogen Evaporators – 03.
• Refrigerated Centrifuge - 01
• Deep Freezer (-20°C : 02) and (-70°C : 02 )
• Eurotherm monitoring system : 01 (12 Channel)

All the equipments in BA lab use validated software that is CFR 21 Part 11 compliant. The Bio-Analytical data is from all the studies is comprehensively audited by the Quality Assurance and subjected to periodic in-house audits to ensure compliance.