Strategic Regulatory Partner for Success in Saudi Arabia

Greetings from

Pharma Wizard Saudi Arabia

Pharma Wizard 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 Pharma Wizard 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), 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 in Saudi Arabia

Saudi Food and Drug Authority (SFDA) is the key Drug Regulatory Authority in Saudi Arabia, enforcing SFDA drug registration regulation and ensuring compliance with SFDA drug registration requirements to maintain the safety and quality of medicinal products. The drug department of the SFDA is responsible for handling and licensing of the manufacture, import, export, distribution, promotion, and advertising of medicinal products. SFDA is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and monitoring the quality & safety of the marketed medicinal products.
• End-to-end Pharmaceutical Product Registration
• Authorized Local Agent Support
• GMP Support
• Dossier Gap Analysis as per the SFDA Regulatory Requirements
• Preparation of Gap Analysis Report and Remediation Plan
• Pharmaceutical Dossier Preparation and Submission to the SFDA

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

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