English
We have extensive experience in our field, so we can provide you with distinguished services.
With extensive experience in navigating Saudi Food and Drug Authority (SFDA) systems, our expert regulatory consultants support clients across multiple sectors. We handle the registration and compliance process for medical devices, cosmetics, food, food supplements, animal feed, and more ensuring your products meet all SFDA requirements.
As specialists in registering medical devices with the SFDA,we will assist you in registering your medical devices. Our team will review your technical documentation, product data, ensures compliance with Authority's standards, and guides you through every step of the approval process for smooth and efficient market entry.
We help you appoint a licensed Authorized Representative in Saudi Arabia for the registration and marketing of your medical devices. Our team guides you through the process to obtain the Authorized Representative license from SFDA, ensuring full regulatory compliance and seamless market access.
We assist companies in obtaining a Medical Device Establishment License (MDEL) in Saudi Arabia, enabling them to legally import, distribute, and manufacture medical devices in full compliance with regulatory requirements.
We help businesses establish and register warehouses for medical devices, cosmetics, drugs and food products, ensuring full compliance with regulatory requirements and smooth operations.
We assist manufacturers to successfully transfer their local Authorized Representative in Saudi Arabia, including the seamless transfer of associated product licenses (MDMA), ensuring regulatory compliance and continuity of market access.
Get licensed to maintain medical devices safely and in full compliance with regulations.We assist establishments in obtaining a Medical Device Maintenance Provider License, ensuring compliance with regulatory requirements and enabling safe, authorized maintenance of medical devices.
We facilitate the issuance of ISO certificates from IAF-accredited certification bodies and provide tailored ISO 13485 quality manual checklists to simplify establishment registration and ensure smooth regulatory compliance.
We handle the submission of release requests through the Faseh system, ensuring smooth and compliant clearance of medical devices, food, and cosmetic products into the Saudi market.
Issue a Certificate of Conformity (CoC) for cosmetic products.
We assist companies in registering with NUPCO, the centralized healthcare procurement platform in Saudi Arabia. Our support ensures your establishment meets all requirements to participate in government tenders, supply medical devices, pharmaceuticals, and healthcare products, and smoothly access new business opportunities in the Saudi healthcare sector.
We offer comprehensive support for local and international investors looking to establish businesses in Saudi Arabia. Our services cover investment, industrial, municipal, and commercial licenses, trade name reservation, and the setup of Ministry of Human Resources and social insurance files, ensuring a smooth and fully compliant business setup process.
We help your organization develop procedures and comprehensive work and operation plans fully aligned with regulatory authority requirements.
We provide personalized services based on client needs, offering tailored solutions and full regulatory compliance with SFDA. Contact us to know more.
