Regulatory Affairs Services
Navigate Africa's complex regulatory landscape with confidence. Our expert team provides comprehensive support for product registrations, compliance, and regulatory strategy across the continent.
Comprehensive Regulatory Support
End-to-end regulatory solutions tailored to African markets
Product Registration
Complete support for new product registrations across African regulatory authorities. We handle dossier preparation, submissions, and follow-up to ensure timely approvals.
Variation Management
Expert handling of post-approval changes including formulation updates, manufacturing site changes, and label modifications across multiple jurisdictions.
Regulatory Compliance
Ensure ongoing compliance with evolving regulatory requirements. We monitor changes and implement necessary updates to maintain your product licenses.
License Renewals
Timely management of product license renewals across all African markets. We track renewal dates and ensure continuous market authorization.
Dossier Compilation
Preparation of high-quality regulatory dossiers in CTD, eCTD, and local formats. Our team ensures completeness and compliance with regional requirements.
Authority Liaison
Direct communication and relationship management with regulatory authorities. We represent your interests and facilitate smooth approval processes.
Our Regulatory Process
A systematic approach to regulatory success
Gap Analysis
Assess regulatory requirements and identify documentation gaps
Strategy Development
Create tailored regulatory strategy for target markets
Dossier Preparation
Compile comprehensive regulatory submissions
Submission & Follow-up
Submit applications and manage authority queries
Approval & Maintenance
Secure approvals and maintain ongoing compliance
Ready to Expand Your Market Access?
Partner with ECP for expert regulatory affairs support across Africa
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