Product Registration
Complete support for new product registrations across African regulatory authorities. We handle dossier preparation, submissions, and follow-up to ensure timely approvals.
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.
Service 02 / 0702What we deliver
Comprehensive Regulatory Support
End-to-end regulatory solutions tailored to African markets
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.
Why ECP
Local expertise. Global standards.
A consortium of professionals with over 15 years of experience and in-depth knowledge of African Medicines Regulatory Authorities and the standards they apply.
- Nairobi-based specialists with regional reach across 25+ countries
- A multidisciplinary team covering regulatory, clinical, safety and quality
- A track record with leading pharmaceutical organisations
How we work
Our Regulatory Process
A systematic approach to regulatory success
1
Gap Analysis
Assess regulatory requirements and identify documentation gaps
2
Strategy Development
Create tailored regulatory strategy for target markets
3
Dossier Preparation
Compile comprehensive regulatory submissions
4
Submission & Follow-up
Submit applications and manage authority queries
5
Approval & Maintenance
Secure approvals and maintain ongoing compliance
Related work
See it in practice.
2015
2016-2017
Grünenthal Pharmaceutical Project
Provided regulatory intelligence and guidance for branded generic registrations and regulatory maintenance in Kenya.
GSK Projects
Supported PAREXEL's GSK Vx Divestment project, regulatory strategy for Kenya and Nigeria, and restructuring of pharmaceutical operations in Sub-Saharan Africa.
Continue exploring
Other ECP services.
03
Clinical Research
Clinical trial support, site selection, regulatory approvals and pharmacovigilance services.
04cGMP Compliance
GMP audits, quality system implementation and preparation for regulatory inspections.
05Regulatory Medical Writing
Clear, concise and compliant regulatory and medical writing, delivered by expert writers.
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Ready to Expand Your Market Access?
Partner with ECP for expert regulatory affairs support across Africa. Tell us about your product and target markets and we will respond with a clear next step.