Greetings from Freyr Saudi Arabia
Freyr is a global Regulatory leader providing services and solutions to Life Sciences companies in their entire Regulatory value chain. With our presence in 120+ countries, we help Life Sciences companies in their “local to global” journey. At Freyr Saudi Arabia, we support companies in navigating Saudi Food and Drug Authority regulations and guidelines and registering their products with the Saudi Food and Drug Authority (SFDA). Our expertise spans Pharmaceutical Regulatory Affairs in Saudi Arabia, Regulatory strategy, market intelligence, in-country representation, PMS functions, and more. We also offer next-gen Regulatory software solutions covering the complete SFDA registration process.
Industries We Serve
The Saudi Food and Drug Authority is the key Regulatory authority in Saudi Arabia, enforcing SFDA drugs (human and veterinary), medical devices, cosmetics, food, and food supplements registration regulations and ensuring compliance with Saudi Arabia's Regulatory requirements to maintain the safety, quality, and efficacy of all types of products.
The drug sector of the SFDA oversees the manufacture, import, export, distribution, promotion, and advertising of medicinal products. It is also responsible for evaluating safety, efficacy, and quality, issuing marketing authorizations, and monitoring post-market safety through a structured SFDA approval process and pharmaceutical product registration in the Saudi Arabia framework.
- End-to-end pharmaceutical product registration in Saudi Arabia
- Authorized local agent support (mandatory for foreign manufacturers)
- Supporting GMP compliance to SFDA requirements
- Dossier gap analysis as per SFDA Regulatory requirements
- Preparation of gap analysis report and remediation plan
- Pharmaceutical dossier review, preparation, and eCTD submission at the Saudi Arabia FDA
Healthcare in the Kingdom of Saudi Arabia (KSA) is recognized as a prime sector by the government of the KSA, and there is a growing need for Medical Devices in the country. The Saudi Food and Drug Authority (SFDA), reporting to the Council of Ministers, regulates the Medical Devices in the KSA. Saudi Arabia medical device regulations are influenced by cultural inclinations. In the country, linguistic barriers, rigorous scrutiny are the major bottlenecks to further proceed for device approval.
- Regulatory Intelligence on Saudi Arabia Medical Device Registration
- End-to-end Saudi Arabia Medical Device Registration
- MDNR Listing and MDMA Approval
- Saudi Arabia Authorized Representation
- Query Support Management till Approval
- Artwork Management
The Saudi Arabian Nutraceuticals/Food market is largely dominated by functional foods. Baby foods and milk formulas, which come under functional foods, stand as the largest segments in demand. The Saudi Food and Drug Authority (SFDA) is the Saudi government agency responsible for establishing regulations and standards for compliance of concerning food, unprocessed and processed animal feed products.
- Product Classification
- SFDA Food LicenseRegistration Support
- Formula Review/Ingredients Assessment
- Label and Claims Review
- Dossier Gap Analysis and Review
- Compilation and Submission of Dossier for SFDA Food Registration
The Kingdom of Saudi Arabia (KSA) is regarded as one of the richest economieswith high standards of living, and with immense demand for a wide range of cosmetic products, the cosmetics market in the region stand lucrative. In the KSA, the Saudi Food and Drug Authority (SFDA) is responsible for regulating the development, import, distribution, sale and marketing of cosmetics.
- Product Classification
- Formulation Review
- Claims Review
- Regulatory Intelligence
- Labeling Review
- eCOSMA Registration
Freyr Digital
An Innovative, Cloud-hosted, AI/ML enabled Regulatory Intelligence platform offering a complete spectrum of authoritative Regulatory Information
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Largest global ingredients repository and Regulatory database to support digitization of formulation assessment and real-time intelligence Know More
Freyr SPAR is one such RIM Solution that enables Life Science organizations to effectively manage the information right from tracking product registrations to generate statistical reports.
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About Freyr
Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.
Know MoreOur Regional Expertise
We are a global firm and we have local expertise across the following countries.
