Our Services
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.
Capabilities
Core Capabilities
End-to-end regulatory and compliance support across the MENA region.
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.
Sectors
Sector-Specific Hubs
Explore regulatory services tailored to your industry.