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Pharmaceuticals Expertise

  • End-to-end Pharmaceutical Product Registration 
  • Authorized Local Agent Support
  • GMP Support
  • Dossier Gap Analysis as per the SFDA Regulatory Requirements
  • Pharmaceutical Dossier Preparation and Submission to the SFDA
  • Query Support Management until Approval
  • Ad-hoc Regulatory Affairs Consultation
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Overview of the Saudi Arabian
Regulatory Landscape

Saudi Food and Drug Authority (SFDA) is the key Drug Regulatory Authority in Saudi Arabia. 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 for monitoring the quality & safety of the marketed medicinal products. 

 

Industries We Serve

Saudi Food and Drug Authority (SFDA) is the key Drug Regulatory Authority in Saudi Arabia. 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 for 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
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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
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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
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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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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.

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Our Regional Expertise

Being a Globally Local firm, we have our presence in the following countries, click to know more

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