The Saudi Food and Drug Authority (SFDA) serves as the primary regulatory body overseeing the pharmaceutical landscape in Saudi Arabia. Its responsibilities encompass licensing, manufacturing, importing, exporting, distributing, promoting, and advertising medicinal products. The SFDA ensures that only safe, effective, and high-quality products reach consumers by conducting thorough assessments of medicinal products before issuing marketing authorizations. At MedWisdom LifeScience, we are dedicated to supporting these companies in their journey, especially in Saudi Arabia—a key market in the Middle East.
Documents Required for Drug Approval in Saudi Arabia:
- Application Form
- Drug Information File
- Quality Control Data
- Stability Studies
- Preclinical Data
- Clinical Trial Data
- Labeling and Packaging Information
- Risk Management Plan
- Product Samples
- Registration Fee Proof
- Pharmacovigilance Plan
- Certificate of Pharmaceutical Product (CPP)
Fees: https://ghad.sfda.gov.sa/en
Medwisdom Lifescience Offers Diverse Services in Saudi Arabia
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Service Category |
Service Offerings |
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Pharmaceuticals |
Pharmaceutical Dossier Preparation and Regulatory Submission to SFDA |
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GMP Compliance Support |
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Pharmaceutical Product Registration |
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Regulatory Submission Services |
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Medical Devices |
Regulatory Intelligence on Medical Device Registration in Saudi Arabia |
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Saudi Arabia Medical Device Registration Process |
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Medical Device National Registry (MDNR) Listing and Medical Device Marketing Authorization (MDMA) Approval |
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Efficient Query Support Management |
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Labelling and Packaging Compliance Services |
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Cosmetics |
Product Classification and Regulatory Assessment |
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Formulation Review and Compliance Evaluation |
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Regulatory Intelligence for Cosmetics |
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Labelling Review for Regulatory Compliance |
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Electronic Cosmetics Registration |