LC-MS/MS
Bioanalytical Testing
State-of-the-art LC-MS/MS bioanalytical services for pharmaceutical compounds and metabolites in biological matrices.
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Overview
Our bioequivalence studies are designed to demonstrate therapeutic equivalence between generic and reference pharmaceutical products. We conduct single-dose and steady-state studies across various formulations including tablets, capsules, transdermal patches, and complex generics.
KeyBenefits
- FDA-inspected facility with proven track record
- Studies conducted per ICH, FDA, EMA, and WHO guidelines
- 200+ successfully completed BE studies
- Fast turnaround times with flexible scheduling
- Comprehensive statistical analysis and reporting
Methodology
- 1Study protocol development and regulatory submission
- 2Volunteer recruitment and medical screening
- 3Clinical phase with 24/7 medical supervision
- 4Bioanalytical sample analysis using validated methods
- 5Statistical analysis and final study report preparation
- 6Regulatory support for global submissions
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Phase I–IV
Clinical Trials (Phase I-IV)
Full-service clinical trial management from protocol development to final report for all therapeutic areas.
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Submissions
Regulatory Consulting
Expert regulatory guidance for pharmaceutical product registration and compliance across MENA and international markets.
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