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Our Services

Expert Regulatory & Compliance Solutions Across MENA

End-to-end market access, registration, and post-market compliance for Pharmaceuticals, Medical Devices, and Cosmetics in Saudi Arabia, Egypt, and the UAE.

Core Capabilities

Authorized Representation (Local Agent)

Acting as your legal representative before the SFDA, EDA, EDE, and other regional authorities.

Product Registration & Licensing

End-to-end compilation, submission, and management of dossiers for fast market entry.

Variation & Lifecycle Management

Strategic handling of post-approval changes, ensuring continuous compliance without market disruption.

Scientific Committee & Fast-Track Approvals

Expert preparation for committee reviews and leveraging facilitation mechanisms to speed up approvals.

Vigilance & Post-Market Surveillance

Monitoring, reporting, and managing adverse events (Pharmacovigilance, Materiovigilance, Cosmetovigilance).

Quality Management & Compliance Training

ISO/QMS implementation support, compliance auditing, and staff development programs.

Sector-Specific Hubs

Pharmaceuticals

Comprehensive support for human pharmaceuticals, from initial dossier submission (CTD) to post-market variations and safety monitoring.

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Medical Devices

Navigating complex risk classifications and ensuring seamless market access for medical equipment, diagnostics, and accessories.

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Cosmetics

Ensuring safety, efficacy, and regulatory alignment for beauty and personal care products entering the MENA region.

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MRG Quality & Training Programs

MRG offers specialized, industry-leading training programs for healthcare organizations across the MENA region. From regulatory submission management to ISO implementation and post-market vigilance, we equip your team with the knowledge to maintain continuous compliance.

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