Regulatory Affairs Department

Your Gateway to SFDA Compliance and Market Success in Saudi Arabia
At Al-MonaCare Company, we help international manufacturers, local producers, and distributors confidently navigate the Saudi Food and Drug Authority (SFDA) regulatory landscape.
Our expert Regulatory Affairs team simplifies complex procedures—ensuring your products meet all SFDA requirements for registration, licensing, labeling, and market authorization.
From initial submission to post-market support, we provide complete, hands-on guidance to secure timely approvals and maintain compliance in the Saudi market.

We offer tailored regulatory services across multiple sectors:

* Medical Devices – Establishment and product licensing, AR representation, MDMA registration, UDI & labeling, ISO 13485 support, and post-market surveillance.

* Food & Beverages – SFDA product registration, labeling compliance, and safety documentation.

* Cosmetics & Personal Care – Ghad system registration, ingredient review, and packaging compliance.

* Natural & Dietary Supplements – Product registration, labeling, and health claims validation.

* SABER (SASO) – Product and shipment conformity, account management, and customs clearance.

We combine deep regulatory expertise with a proactive, client-centered approach, helping your business achieve fast, compliant, and sustainable market access in Saudi Arabia.
Whether you’re entering the market for the first time or managing an existing product portfolio, we make SFDA compliance simple, reliable, and growth-driven.

Email: registration@almonacare.com