BE / BA Studies
Bioequivalence Studies
Comprehensive BE/BA studies conducted in accordance with FDA, EMA, and WHO guidelines for generic drug approval.
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Overview
Our bioanalytical laboratory is equipped with the latest generation LC-MS/MS systems capable of analyzing complex pharmaceutical compounds with exceptional sensitivity and accuracy. We provide method development, validation, and sample analysis for clinical and preclinical studies.
KeyBenefits
- Multiple LC-MS/MS systems for high throughput
- Sub-picogram detection limits (pg/mL)
- ISO 17025:2017 accredited laboratory
- Validated methods for 500+ pharmaceutical compounds
- Regulatory-compliant documentation and data integrity
Methodology
- 1Method development and optimization
- 2Full method validation per regulatory guidelines
- 3Sample analysis with quality control samples
- 4Data processing and statistical evaluation
- 5Complete analytical report with QC documentation
- 6Long-term sample storage at -80°C
RelatedServices
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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