MENA REGION EXPERTISE

Safety & Regulatory Affairs
Consulting Excellence

Morocco-based regulatory consulting firm with deep expertise across the MENA region. We provide comprehensive safety and regulatory affairs services through our network of local consultants and strategic partnerships, ensuring seamless market access and regulatory compliance.

15+
MENA Markets
50+
Regional Consultants
100%
Local Compliance
24/7
Regional Support

Our Core Services

Comprehensive regulatory affairs and safety services designed to navigate the complex MENA regulatory landscape with local expertise and strategic partnerships.

Regulatory Strategy

Strategic regulatory guidance across MENA markets with deep understanding of local requirements, submission pathways, and approval processes.

Market access strategy
Regulatory submissions
Approval pathway optimization

Safety & Pharmacovigilance

Comprehensive safety monitoring, adverse event reporting, and pharmacovigilance services aligned with regional regulatory requirements.

ICSR processing & reporting
Safety database management
Risk management plans

Regional Partnership Network

Extensive network of regulatory consultants and strategic partners across MENA ensuring local expertise and seamless market access.

Local regulatory experts
Strategic partnerships
Cross-border coordination
Morocco-Based, MENA-Wide

Regional Regulatory Affairs Expertise & Network

Based in Morocco with extensive operations across the MENA region through our network of regulatory consultants and strategic partnerships, ensuring comprehensive market coverage and local expertise.

Morocco Hub Operations

Strategic headquarters in Morocco with deep understanding of Maghreb regulatory landscape.

MENA Regional Network

Extensive consultant network across GCC, Levant, and North Africa ensuring local market access.

Local Regulatory Intelligence

Real-time regulatory updates and market intelligence across all MENA jurisdictions.

15+
MENA Markets
100%
Local Compliance
50+
Regional Consultants
24/7
Regional Support

Detailed Service Offerings

Comprehensive regulatory affairs and safety services designed to meet the unique requirements of each MENA market.

Regulatory Submissions

Expert preparation and submission of regulatory dossiers, CTD modules, and market authorization applications.

Local Expertise

Regional consultants with deep market knowledge and established relationships with regulatory authorities.

Market Intelligence

Continuous monitoring of regulatory landscape changes and competitive intelligence across MENA markets.

Market Access Strategy

Strategic planning for optimal market entry pathways and regulatory approval timelines.

Safety Reporting

Comprehensive adverse event reporting, ICSR processing, and safety signal management services.

Database Management

Safety database setup, maintenance, and validation ensuring regulatory compliance and data integrity.

Risk Management

Development and implementation of risk management plans and risk evaluation mitigation strategies.

Regulatory Liaison

Direct communication and relationship management with regulatory authorities and health ministries.

Ready to Navigate MENA Markets?

Our team of regulatory experts is ready to help you achieve successful market access across the MENA region.

Schedule Your Consultation