GMP Audits & Inspections
Comprehensive facility audits to assess compliance with local and international GMP standards. We identify gaps and provide actionable recommendations for improvement.
cGMP Compliance Services
Ensure manufacturing excellence and regulatory compliance with our comprehensive GMP auditing, consulting, and quality assurance services across Africa.
Service 04 / 0704What we deliver
Comprehensive GMP Support
Maintain the highest quality standards in pharmaceutical manufacturing
Manufacturing Site Qualification
Support for new facility setup and qualification. We ensure your manufacturing sites meet all regulatory requirements before product approval.
Quality System Development
Design and implementation of robust quality management systems. We develop SOPs, quality manuals, and documentation systems tailored to your operations.
Vendor Qualification
Comprehensive vendor auditing and qualification programs. Ensure your supply chain partners meet GMP requirements and quality standards.
GMP Training Programs
Customized training for manufacturing personnel at all levels. We build internal GMP expertise and foster a culture of quality compliance.
Remediation Support
Expert guidance to address regulatory findings and implement corrective actions. We help you respond effectively to inspection observations.
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 GMP Compliance Process
Systematic approach to manufacturing quality
1
Gap Assessment
Evaluate current state against GMP requirements
2
Action Planning
Develop comprehensive remediation roadmap
3
Implementation
Execute quality system improvements
4
Verification
Validate effectiveness of implemented changes
5
Continuous Improvement
Ongoing monitoring and optimization
Continue exploring
Other ECP services.
05
Regulatory Medical Writing
Clear, concise and compliant regulatory and medical writing, delivered by expert writers.
06Labeling & Artwork
End-to-end labeling services and comprehensive solutions for artwork management.
07Pharmacovigilance
Drug safety and efficacy assured through comprehensive pharmacovigilance services.
Begin
Achieve Manufacturing Excellence
Partner with ECP for expert cGMP compliance support across Africa. Tell us about your product and target markets and we will respond with a clear next step.