Transforming Your Business Potential into Market Leadership

At UniFusion B.S.C, we specialize in providing comprehensive regulatory consultation for Medical Devices, IVDs, Pharmaceuticals, and Cosmetics in Saudi Arabia, ensuring seamless SFDA approvals through strategic compliance management. As an Authorized Representative, we facilitate product registration, market authorization, and ongoing compliance, handling all regulatory interactions with SFDA on behalf of manufacturers.

Our expertise covers pre-and post-market surveillance requirements, and efficient, risk-mitigated market entry. We provide adverse event monitoring, and renewal management to uphold the highest industry standards.

Additionally, we guide manufacturers through classification, labeling compliance, stability testing, bioequivalence studies, and product variation updates, enabling businesses to meet Saudi Arabia’s evolving regulatory landscape with confidence. Our commitment to excellence, integrity, and client satisfaction allows manufacturers to focus on innovation while we navigate regulatory complexities, ensuring compliance, accelerating approvals, and driving long-term success in the Saudi healthcare and consumer markets.

Partner with UniFusion B.S.C—where expertise meets efficiency in regulatory solutions.