Regulatory Affairs

At Shifa Alalil Medical LLC, we provide end-to-end regulatory solutions to ensure smooth and compliant market entry for pharmaceutical and healthcare products in the UAE.

Our expert regulatory team manages the complete process—from documentation evaluation to submission—ensuring full compliance with the UAE Ministry of Health and Prevention (MOHAP) and other relevant authorities. We work closely with our partners’ regulatory departments to meet all mandatory requirements efficiently and accurately.

 

Marketing Authorization & Licensing

  • Registration of Marketing Authorization Holders (MAH)
  • Registration of Manufacturing Sites
 
 

Medicinal Product Registration

  • Conventional pharmaceutical products
  • Biological products
  • Over-the-Counter (OTC) medicines
 
 

Specialized Product Registration

  • Natural medicines (Herbal & Homeopathic)
  • Medical devices, including AI-powered healthcare software
 
 

Consumer & Health Product Registration

  • Cosmetics
  • Health supplements
  • Food products
  • Antiseptic products (registered with Dubai Municipality)
 
 

Additional Regulatory Support

  • Medical Store Endorsement Applications
  • Product transfer facilitation to authorized drug stores
 
 
 

Our Regulatory Services

We offer a comprehensive range of regulatory support services, including:

Strategic Market Activation

After regulatory approval, our marketing team collaborates with partners to launch targeted promotional strategies, ensuring successful product positioning and commercial growth in the UAE market.

Market Access & Insurance Inclusion

We go beyond registration to support full market access.

Our team ensures the inclusion of approved products in key healthcare systems, including:

  • Dubai Drug Code (DDC)
  • Health Authority Abu Dhabi (HAAD)
  • Insurance provider networks

Once listed and approved for insurance coverage, products can be prescribed by doctors across public and private hospitals—significantly enhancing market penetration.

 

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