- What We Provide
Core Services & Expertise
Pre-Clinical & Diagnostic / Device Studies
- Feasibility assessments
- Study design support for diagnostic/device validation
- Protocol development for pre-clinical, clinical, device studies etc.
- Compliance support (e.g. regulatory strategy for diagnostics / devices)
Regulatory Consulting & Vendor Management
- Regulatory pathway strategy for clinical, diagnostics & device studies
- Guidance on submissions, regulatory compliance
- Vendor selection, contract oversight, vendor risk assessment & monitoring
Real-World Data / Epidemiology / Post-market / RWD Studies
- Study design & planning for observational / real-world evidence generation
- Data collection planning, analysis support
- Post-market surveillance / registries / observational cohort studies
Risk Mitigation & Compliance Support
- Risk assessments & contingency planning for all study types
- Project oversight support to ensure compliance and quality under tight timelines
- Interim support to manage QC backlogs or transitional periods
Clinical Trial Services
- Clinical trial planning & management
- Site/vendor selection and oversight (vendor management)
- Data management and QC support
- Project-based support for sponsors or CROs without full internal capacity
Quality Assurance / Method Validation / Inspection Readiness
- Quality management system reviews & gap analyses
- Inspection-readiness assessments & mock-audit preparation
- TMF QC, document management support
- Method validation studies (for diagnostics / lab work)
Training & Development
- GCP training (for clinical research and other staff)
- SOP writing and quality documentation training
- Compliance & QA training, TMF handling & document-specialist training
- Customized training modules tailored to biotech / MedTech start-ups or small teams
What Makes NAMI Different
NAMI combines global industry expertise with a proven, long-standing operational presence across Sub-Saharan Africa, including East and West Africa. Our team brings decades of hands-on experience working within complex regulatory landscapes, diverse healthcare systems, and resource-variable environments. We have established expertise in tropical and rare diseases, where deep regional knowledge, strong local partnerships, and strict adherence to international quality and compliance standards are essential. This unique integration of global best practices with local execution enables NAMI to support sponsors and CROs in delivering ethically sound, regulator-ready, and operationally feasible studies across emerging and high-need regions.
– Tailored, flexible consulting to suit small- to medium-sized sponsors, biotech or MedTech start-ups
– Broad service spectrum: from preclinical/diagnostics to regulatory strategy, QA, clinical operations, and training — reducing the need for multiple vendors
– Deep regulatory & quality awareness to mitigate risk and ensure inspection-readiness
– Rapid scaling — interim or functional support for teams that can’t afford full-time staff
– Transparent pricing and clear packages — helpful for start-ups and SMEs
– Client-centric: dedicated consultants, regular progress reports, resource access, ongoing support