We provide local market expansion services for selected products in a variety of therapeutic areas through our local partners. Our main focus is the MENA region.
With our powerful partner network, we develop and execute go-to-market strategies for the licensed products and strive to maximize their commercial success.
Together with our partners, we are able to suggest market access solutions to assist our clients in bringing their products to market effectively by knowing the business demands of clients, the key decision makers, and the path to market.
- EU establishment, quality management systems, licenses, and compliance
- Communicate with Healthcare Technology Assessment (HTA) organizations
- Regulatory guidance on branding
- Local assistance for the implementation of market access through our network, Medspero
- Regulatory approach with proper submission formats
- Verifying the trade name, manufacturer, INCI(s), CAS/EINECS, and the percentage or constituent
- Analyze any potential effects on new guidelines, restrictions, and/or the need for reporting and documentation/requirements.
- The proper regulatory and drug registration process when regional complexity is present (e.g. EU – National Procedure, De Centralized Procedure-DCP, Mutually Recognized Procedure-MRP)
- Changes in toxicology, regulatory, and environmental legislation should be monitored.