A quality system exists on paper but not in daily practice. Procedures are written but unmanaged, records are inconsistent, quality ownership is fragmented, and departments operate in silos. Certification remains out of reach, and upcoming regulatory inspections pose significant compliance risks.
Evaluate your current QMS architecture against ISO 9001:2015, ICH Q10, or applicable GxP standards.
Present compliance gaps in clear terms and establish comparative baseline readiness scores.
Build costed, step-by-step roadmaps specifying owners, milestones, and realistic timelines to certification.
Assist in drafting quality manuals, standard operating procedures (SOPs), and quality policies.
Establish management review, internal audit, deviation handling, and CAPA management workflows.
Guide your leadership and quality teams through to the formal certification audit.
Executive awareness briefings for senior leadership, technical ISO 9001:2015 requirements training for quality teams, and internal auditor skills development.
On-site QMS assessments of 17 national regulatory authorities, delivering custom roadmaps to ISO 9001:2015, followed by regional validation workshops and training in Lagos for all 15 ECOWAS authorities. Five assessed authorities now hold ISO 9001:2015 certification (FDA Ghana, NAFDAC Nigeria, LMHRA Liberia, Pharmacy Board of Sierra Leone, MCA The Gambia).
Quality compliance gap analysis, CAPA closure, remediation roadmap, and global SOP harmonisation across UK, European, and Asian sites.
Led by Dr Chinedu Madichie (CQI/IRCA Certified ISO 9001 Lead Auditor), working alongside Mr Bolarinwa Yusuf (former NAFDAC Quality Manager who implemented ISO 9001:2015 agency-wide), Mr Benjamin Botwe (former Acting CEO of Ghana FDA), and Dr Kole Ido (institutional quality capacity specialist).
