Bioequivalence Study Services
Protocol to clinical report, designed, dosed, sampled and monitored in our own unit.
What this covers
Bioequivalence studies designed and run to SFDA and international requirements, keeping your generic development programme closer, simpler, and more efficient.
Study design and conduct
Design and conduct of bioequivalence studies across fasting, fed, and steady-state conditions, in full alignment with SFDA and ICH-GCP requirements.
End-to-end protocol development
Including scientific rationale, study design selection, and regulatory-ready amendments.
Statistical planning
Robust sample size calculation and statistical planning to ensure adequate power, regulatory acceptance, and optimized timelines.
Supervised clinical conduct
Controlled subject housing, dosing, blood sampling, and compliance monitoring within a supervised clinical research environment.
Our on-ground teams ensure predictable timelines, consistent site performance, and global-quality execution.
Ready to run your BE programme in the Kingdom?
Tell us the molecule, the dosage form and the timeline you are working to. We will come back with a study design and a schedule.