Diagnosing Quality Compliance Gaps for a Global Consumer Healthcare Business
A global consumer healthcare company experienced persistent quality compliance gaps across international manufacturing sites, with site quality culture and audit readiness scoring below 50%.
Requalifying a Clinical Supply Vendor for UK Research Operations
A UK-based clinical research organization required independent verification of a key investigational medicines distribution vendor to ensure strict compliance with Good Distribution Practice (GDP) and Good Clinical Practice (GCP).
Planning Automation for Regulatory Change Management
Process mapping and an AI/automation implementation roadmap for global manufacturing change submissions, enabling the client to realise over €2m in recurring annual efficiency savings.
Appraising a US$3M World Bank-Funded Regulatory Harmonisation Programme
WAHO and the World Bank required an independent, rigorous end-of-project appraisal of the US$3m West African Medicines Regulatory Harmonisation (WA-MRH) initiative to evaluate achievements, governance, and long-term sustainability across 15 countries.
Mapping Medicines Manufacturing Across West Africa
A region-wide study mapping, quantifying, and evaluating local pharmaceutical manufacturing capacity and policy constraints across all 15 ECOWAS member states, with strategic recommendations validated by regional stakeholders.
Assessing 17 National Medicines Regulators
On-site QMS assessments of 17 national medicines regulatory authorities, custom roadmaps to ISO 9001:2015, and regional validation workshops and training across ECOWAS member states. Five assessed authorities subsequently achieved full ISO 9001:2015 certification.