End-to-End Regulatory Support for Pharmaceutical Products Across the Middle East
The Middle East is an evolving pharmaceutical market characterized by robust healthcare investments, an increasing focus on quality medicines, and diverse regulatory frameworks. However, navigating these country-specific regulations requires a knowledgeable and reliable partner.
RABT Global offers comprehensive Regulatory Services for Pharmaceuticals across the Middle East. With a strong understanding of local and regional regulatory environments, we help pharmaceutical companies achieve swift, compliant, and efficient market access.
Our Comprehensive Regulatory Services
1. Regulatory Intelligence & Strategic Consulting
Country-specific regulatory insights (GCC & non-GCC)
Product classification and registration pathways
Regulatory strategy development and risk mitigation plans
2. Dossier Preparation & Product Registration
Preparation of dossiers in CTD/eCTD formats as per regional authority requirements
Coordination with health authorities for submission and approvals:
SFDA (Saudi Arabia)
MOHAP (UAE)
CAPA (Egypt)
Qatar MOPH, Kuwait MOH, and others
Lifecycle management (variations, renewals, responses to queries)
3. GMP Compliance & Site Registration
Guidance and support in Good Manufacturing Practice (GMP) audits
Assistance with site registration and manufacturing facility inspections
Preparation of GMP-related documents and readiness checks
4. Local Agent & Pharmacovigilance Support
Acting as a Local Authorized Representative (LAR) where required
Local PV officer support, literature monitoring, ICSR submissions
Risk management plans and regulatory reporting
5. Import License & Market Access Services
Assistance in securing import licenses for commercial and clinical use
Product distribution compliance and label verification
Coordination with in-country distributors and agents
6. Post-Market Surveillance & Regulatory Maintenance
Periodic Safety Update Reports (PSURs) and signal detection
Response management for adverse events and recalls
Continuous tracking of regulatory changes and impact analysis
Coverage Across Middle Eastern Markets
RABT Global provides pharmaceutical regulatory support in:
Saudi Arabia (SFDA)
United Arab Emirates (MOHAP, DHA, HAAD)
Egypt (CAPA)
Qatar (MOPH)
Oman
Kuwait
Bahrain
Jordan
Why RABT Global?
Expertise in Middle Eastern Regulatory Frameworks
Strategic and Operational Regulatory Services
Strong Liaison with Local Authorities
Support Throughout the Product Lifecycle
Dedicated Team for Compliance and Market Success
Planning to register and commercialize your pharmaceutical products in the Middle East? Partner with RABT Global for reliable, fast, and compliant regulatory solutions.
