Bioequivalence Studies That Reflect Real-World Use
Some products require bioequivalence (BE) to be demonstrated in patient populations. We bring scientific and operational expertise to manage these complex trials.
Why This Service Matters
When traditional BE in healthy volunteers isn’t enough — due to safety, disease-specific kinetics, or regulatory needs — patient-based studies are required.
Our Key Capabilities
End-to-end clinical trial management you can trust
📋 Protocol Development & Regulatory Strategy
- Regulatory submissions with CDSCO, USFDA, EMA
- Therapeutically appropriate patient cohort design
- Ethics approvals and review
🏢 Patient Site Management
- Site feasibility and contracting
- Disease-specific investigator engagement
- Real-world safety monitoring
🧠 PK/PD Analysis
- Bioanalytical method setup
- Sample management and processing
- PK/PD modeling and BE report generation
🩺 Therapeutic Area Expertise
- Oncology
- CNS & Psychiatry
- Infectious Diseases
- Cardiometabolic Disorders
- Rare & Orphan Diseases