Health Solutions
Empowering Health Innovations
Regulatory Support for Healthcare Products
We provide comprehensive regulatory support for the registration of medicines and medical devices in Ethiopia, working with the Ethiopian Food and Drug Authority (EFDA) to ensure all requirements are met.
Medicine Registration
Complete regulatory support for registering medicines with EFDA, ensuring compliance with all quality, safety, and efficacy standards.
Medical Device Registration
Expert guidance for medical device registration, covering all regulatory pathways and product classifications.
Our Clients
We work with diverse organizations committed to bringing quality healthcare products to Ethiopia
International Manufacturers
Global companies seeking to register their products in the Ethiopian market
Local Importers
Ethiopian businesses importing healthcare products for distribution
NGOs
Non-governmental organizations bringing healthcare solutions to communities
Healthcare Institutions
Hospitals, clinics, and healthcare facilities requiring medical products
How We Guide You
A comprehensive approach from initial assessment to final approval
Regulatory Assessment
Initial evaluation of your product and regulatory requirements
Market Analysis
Understanding market conditions and regulatory pathways
Dossier Preparation
Compiling all required documentation and evidence
Submission
Filing your application with EFDA
Authority Liaison
Maintaining clear communication with regulatory authorities
Follow-up
Tracking progress and ensuring efficient approval process
Regulatory Requirements We Cover
Ensuring your products meet all EFDA standards and regulations
Quality
Safety
Efficacy
Performance
Risk Classification
Labeling
Packaging
Shelf Life
Independent Regulatory Partner
Sozo Consulting does not manufacture, sell, or distribute healthcare products. We act as an independent regulatory partner.
We connect clients with reliable and compliant local distributors when required.
Experienced in navigating EFDA's regulatory pathways and product classifications for timely and accurate approvals.
What We Do
- Provide regulatory consulting services
- Guide through EFDA registration process
- Connect with compliant distributors
What We Don't Do
- ✗Manufacture healthcare products
- ✗Sell or distribute products
- ✗Act as a manufacturer or distributor
Supporting Safe Access to Quality Healthcare
Our work is driven by a clear purpose: supporting safe access to high-quality medicines and medical devices and contributing to the strengthening of Ethiopia's healthcare system.
Safe Access
Ensuring patients have access to safe, quality medicines and medical devices
Healthcare Strengthening
Contributing to the strengthening of Ethiopia's healthcare system
Knowledge Transfer & Training
Driving sustainable healthcare improvement through structured knowledge exchange
Beyond Regulatory Support
We place strong emphasis on knowledge transfer as a driver of sustainable healthcare improvement.
Interactive Engagement
Structured, interactive engagement rather than one-way information sharing
What We Deliver
Professional Training Programs
Comprehensive training for healthcare professionals to enhance skills and competencies
Technical Workshops & Seminars
Hands-on workshops covering latest evidence and proven practices
Capacity-Building Sessions
Targeted sessions for clinical and operational teams to strengthen capabilities
Ready to Register Your Healthcare Products?
Let us guide you through the EFDA registration process with expertise and efficiency.