Regulatory Affairs

As a registered Scientific Office, we offer comprehensive Regulatory Affairs services to ensure full compliance with the Emirates Drug Establishment (EDE) in the UAE. Our team of experts collaborates closely with local regulatory ministries and international partners to streamline registration and approval processes for healthcare products. 

Our Services Include: 

• Site Registration Support: Comprehensive manufacturing site registration service with EDE. 
• Product Registration: End-to-end management of dossiers (CTD, eCTD) aligned with UAE regulatory requirements. 
• Regulatory Consultation: Customized compliance strategies based on product type. 
• Labeling & Artwork Review: Ensuring all packaging and inserts meet local regulatory requirements. 
• Regulatory Updates: Real-time monitoring and updates on regulatory changes to ensure ongoing compliance. 
• Renewals & Variations: Lifecycle management, including renewals and modifications to existing authorizations. 

 As a marketing Office, we offer tailored Marketing and Business Development services to support the successful launch, growth, and market penetration of healthcare products across the UAE region.  

Our Services Include:  

• Market Access Strategy Identifying regulatory pathways, pricing strategies, and competitive positioning for new products.  
• Product Launch & Brand Planning End-to-end support for product introductions, including launch planning, promotional material development, and medical marketing.  
• Stakeholder Engagement Building strong relationships with healthcare professionals, regulatory bodies, distributors, and key opinion leaders (KOLs).  
• Business Partner Identification Facilitating connections with reliable local distributors, hospitals, and pharmacy chains.  
• Market Intelligence & Analysis Providing actionable insights on market trends, competitor activity, and growth opportunities.  
• We help our partners expand their footprint in the region with strategic, compliant, and market-driven approaches.