Client & Dates
West African Health Organisation (WAHO) | 2015–2018
Client Challenge
National medicines regulatory authorities (NMRAs) across West and Central Africa faced variable institutional capacity, fragmented quality documentation, and lack of alignment with international ISO 9001 quality standards.
BethAri’s Role
Appointed lead quality consultancy to perform comprehensive on-site QMS assessments, establish baseline readiness rankings, and build national roadmaps to certification.
Approach
Executed two on-site assessment phases: 7 authorities in November 2015 and 10 in November–December 2017 (spanning all 15 ECOWAS member states, Mauritania, and Chad). Spent 2 days on site per authority evaluating processes against ISO 9001. Convened regional validation workshops and delivered 3 days of technical QMS training in Lagos (April 2018). Delivered in English and French.
Deliverables
Two comprehensive regional assessment reports (34 and 88 pages), country-specific QMS gap findings, comparative readiness scoring, and custom 16-step roadmaps to ISO 9001:2015 certification for each regulator.
Evidenced Results
Established the first comparative QMS baseline across 17 regional regulatory authorities. Following BethAri’s roadmaps and technical training, five assessed authorities successfully achieved formal ISO 9001:2015 certification:
- Food and Drugs Authority (FDA), Ghana
- National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria
- Liberia Medicines and Health Products Regulatory Authority (LMHRA)
- Pharmacy Board of Sierra Leone
- Medicines Control Authority (MCA), The Gambia
Contributing Experts
Dr Chinedu Madichie (Lead), Mr Benjamin Botwe, Dr Kole Ido, and Francophone Regional Assessors.