Import and Regulatory Consulting Services
Expert consulting services to help your healthcare business navigate regulatory requirements, optimize operations, and achieve sustainable growth in Ethiopia's healthcare market.
cGMP Pre-Auditing
Expert pre-audit services ensuring compliance with current Good Manufacturing Practices for quality assurance.
Key Features:
Comprehensive facility assessment
Documentation review and gap analysis
Process validation evaluation
Quality system compliance check
Corrective action recommendations
Pre-audit training and preparation
Facility Registration for EFDA cGMP
Assistance in the registration of manufacturing facilities with the Ethiopian Food and Drug Authority to meet regulatory standards.
Key Features:
EFDA registration guidance
Documentation preparation
Compliance verification
Regulatory liaison services
Application submission support
Follow-up and coordination
Product Registration
Comprehensive support for the regulatory processes required for product approval and market entry.
Key Features:
Registration dossier preparation
Regulatory compliance assessment
Clinical data compilation
Labeling and packaging review
Submission and follow-up
Post-approval support
New Facility Establishment
Consultancy services for strategizing and setting up new manufacturing facilities, ensuring operational efficiency and compliance.
Key Features:
Facility design and layout planning
Equipment selection and procurement
Regulatory compliance setup
Quality system implementation
Staff training programs
Operational readiness assessment
Product Selection
Expert guidance in selecting the right products that meet market demands and regulatory requirements.
Key Features:
Market demand analysis
Product portfolio assessment
Regulatory feasibility study
Competitive analysis
Supplier evaluation
Risk assessment and mitigation
Market Assessment and Link
In-depth market analysis to identify opportunities and establish connections for successful product placement.
Key Features:
Market research and analysis
Competitor landscape evaluation
Distribution channel identification
Partnership development
Market entry strategy
Business development support
Tender Participation
Strategic support in preparing for and participating in tender processes to secure business contracts.
Key Features:
Tender identification and analysis
Proposal preparation and writing
Technical documentation support
Compliance verification
Bid submission coordination
Post-tender negotiation support
Pharmaceutical Import & Distribution
We provide comprehensive pharmaceutical import and distribution services, ensuring safe and timely delivery of medications to healthcare facilities across the region. Our cold chain management and quality assurance protocols meet international standards.
Key Features:
Temperature-controlled storage and transport
Real-time inventory management
Regulatory compliance documentation
24/7 emergency supply services
Medical Device Import and Distribution
We provide comprehensive medical device import and distribution services, ensuring safe and timely delivery of medical devices to healthcare facilities across the region. Our cold chain management and quality assurance protocols meet international standards.
Key Features:
Temperature-controlled storage and transport
Real-time inventory management
Regulatory compliance documentation
24/7 emergency supply services
Medical Equipment Supply
From diagnostic equipment to surgical instruments, we supply high-quality medical equipment to hospitals, clinics, and healthcare facilities. Our equipment comes with full warranty, installation, and training services.
Key Features:
Professional installation and setup
Comprehensive staff training programs
Preventive maintenance contracts
Technical support and repairs
Food
Nutritional and dietary products formulated for healthcare settings to support patients' dietary needs.
Key Features:
Temperature-controlled storage and transport
Real-time inventory management
Regulatory compliance documentation
24/7 emergency supply services
Cosmetics
Quality cosmetic products formulated for personal care and enhancement, adhering to safety and regulatory standards.
Key Features:
Temperature-controlled storage and transport
Real-time inventory management
Regulatory compliance documentation
24/7 emergency supply services
Pharmacovigilance
Pharmacovigilance consulting services provide expert solutions for managing and improving drug safety operations. These services cover every stage of the PV lifecycle, from system setup and database management to risk signal detection and aggregate reporting.
Key Features:
Detection
Assessment
Understanding
Prevention
Monitoring
Why Choose Medstar Consulting?
Our deep expertise in Ethiopian healthcare regulations and international standards ensures your success
5+ Years Experience
Deep expertise in Ethiopian healthcare regulations
85+ Successful Projects
Proven track record of regulatory approvals
Expert Team
Qualified professionals with international experience
End-to-End Support
Comprehensive guidance from start to finish
Ready to Get Expert Guidance?
Contact us today to discuss how our consulting services can help your healthcare business succeed.