Bio-Analytical Services

The CEBIS USA BA team is proficient in a variety of bio-analytical services, such as method development, assay validation, and sample analysis using cutting-edge LC/MS/MS technology.

As a provider of comprehensive regulated bioanalytical solutions, CEBIS supports the needs of Research and Development of the pharmaceutical industry.

We collaborate closely with your scientific team to establish robust assays for both parent drugs and metabolites based on our expertise spanning over decades.

Using sub-picogram detection, endogenous, chiral, and hormonal assays, we have expertise in crafting complex proprietary methods for both generics and NCEs and achieve rapid turn-around times. Our team collaborates closely with you in the development and validation of robust, replicable methods.

The data we deliver meets and exceeds quality standards, readily meeting the demands of regulatory agencies.

Bioanalytical Services:

  • Method Development / Method Validation
  • Pharmacokinetic Analysis
  • BA / BE Studies
  • Short and long term sample storage

Our bioanalytical lab has the following amenities:

Each item of equipment in the BA lab runs certified software that complies with CFR 21 Part 11. All of the studies’ bioanalytical data is thoroughly audited by quality assurance, and compliance is periodically checked by internal audits.

  • LC-MS/MS
  • 8,000 square-foot bio-analytical area.
  • Independent Sample Separation / preparation Area.
  • High throughput Solid Phase Extraction Systems
  • Refrigerated Centrifuge
  • Deep Freezer -20°C and -70°C
  • Eurotherm monitoring system for 24x7 temperature and humidity
  • Server for Data storage and backup
  • Provision for normal and light sensitive drugs

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7080, Southwest Fwy,
Houston, Texas – 77074