Vision
To be the leading bioequivalence center in the MENA region, positioning Saudi Arabia as a trusted hub for pharmaceutical research and regulatory excellence.
A bioequivalence partner, based where your study should be
NAMA Bio-Center is a specialized, SFDA-registered bioequivalence center in Saudi Arabia — established under NAMA Research, in partnership with CARE Medical.
What is NAMA BIO-Center, precisely
NAMA Bio-Center is a purpose-built, SFDA-registered bioequivalence partner in Saudi Arabia — running the whole program locally, from protocol design to a submission-ready report.
We were built to localize bioequivalence studies, to take regulatory risk out of the sponsor’s timeline, and to add permanent clinical research capacity to the Kingdom. The first-mover position is deliberate — sponsors get early access, priority scheduling and local expertise at the point where local BE capacity is scarcest — and the unit is designed to expand as regional demand grows.
Why a local center changes the arithmetic
Until now, a Saudi manufacturer proving a generic had to send the study, the samples and the data abroad. Four costs followed from that.
The gap today
No fully operational local BE center
Sponsors have had to outsource abroad, and lose timeline and operational control with it.
Financial and logistical burden
Travel, sample shipment and foreign vendor management are billed on top of the study itself.
Regulatory delay
Clinical and analytical data that is not synchronized locally lengthens SFDA review cycles.
Limited access for local manufacturers
Small and mid-sized companies cannot secure study slots when their submission needs them.
What NAMA Bio does about it
A locally executed bioequivalence programme, built for Saudi regulatory and operational reality.
End-to-end local execution
Clinical conduct through data management, all inside Saudi Arabia.
Saudi population data
BE data drawn from the local population — more relevant, and nationally owned.
SFDA-aligned compliance
Designed and executed to SFDA requirements and ICH-GCP throughout.
Lower cost, shorter timeline
Removing the foreign leg removes its cost, its logistics and its delay.
NAMA Bio-Center exists to close that gap — a reliable, locally governed bioequivalence platform, aligned with national priorities and with what the regulator expects.
Vision and mission
Mission
To deliver high-quality, SFDA & GCC-compliant bioequivalence studies that accelerate generic drug approvals and strengthen Saudi Arabia’s pharmaceutical research ecosystem.
What we hold ourselves to
Five values, and what each one means on an actual study.
Integrity
Ethical conduct and honest reporting at every stage of a study.
Innovation
Scientific rigour applied to better, faster ways of proving equivalence.
Collaboration
Working as an extension of the sponsor’s own regulatory and R&D teams.
Quality
SFDA, ICH-GCP and GLP standards held as the floor, not the target.
Impact
Faster generic approvals, and a stronger national research ecosystem.
Scientific rigour applied to a national priority — a partner sponsors can build a programme around, not a vendor they book once.
Aligned with Vision 2030 — by building the infrastructure, not by citing it
NAMA Bio directly supports Vision 2030 by localizing pharmaceutical R&D and research, reducing dependency on foreign research infrastructure, and enabling the growth of a competitive, innovation-driven life sciences sector in Saudi Arabia.
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.