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Regulatory Services in Saudi Arabia, SFDA, Saudi Arabia regulatory partner

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freyr solutions
Regulatory Services in Saudi Arabia, SFDA, Saudi Arabia regulatory partner


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 to register their products with the 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 life cycle.

Freyr 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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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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Freyr Digital

Freyr SUBMIT PRO, an eCTD Software, Suits All Your Submission Requirements

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An Innovative, Cloud-hosted, AI/ML enabled Regulatory Intelligence platform offering a complete spectrum of authoritative Regulatory Information

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Freyr Label 360 The Real-time is Now REAL Content To Carton.

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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.

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