Quality Built for Regulatory Confidence
At NAMA BIO, every bioequivalence study is conducted within a rigorous quality framework designed to meet SFDA and international standards—with quality embedded in every step, from study conduct to final reporting. Rigorous standards, controlled processes, and scientific expertise—built into every bioequivalence study we conduct.
What each requirement actually governs
Registration, clinical conduct, laboratory practice and regional compliance are four separate requirements. A study has to satisfy all of them at once.
- SFDA registration
- Registered with the Saudi Food and Drug Authority, and designed around its submission pathway from the protocol onward.
- ICH-GCP
- Ethical conduct, participant protection, informed consent, monitoring and data integrity — across the whole study lifecycle.
- GLP bioanalytical standards
- Method development, validation and sample analysis to Good Laboratory Practice, with Eurofins as bioanalytical partner.
- GCC compliance
- Designed to satisfy GCC expectations alongside SFDA, so one study supports registration across the Gulf.
Our quality policies
Compliance is rooms, functions and habits — not a statement on a website.
Data integrity and traceability
QC, documentation and traceability kept current, so the study is audit-ready at any point in it.
Controlled document archive
A dedicated on-site archive holds study records in lockable storage under controlled access.
Dedicated QA function
QA sits beside study coordination. SOPs and audit readiness are a standing function, not a pre-inspection exercise.
National data sovereignty
Because the study runs locally, clinical and pharmacokinetic data stays under control inside the Kingdom.
Auditing us before you commit?
We would rather you did. Ask for the registration certificate, the SOP index, or a walkthrough of the unit — whichever your quality team needs first.