BethAri helps regulators, pharmaceutical businesses, and health programmes build quality systems that pass inspection and regulatory systems that work. Since 2007, our consultants have assessed national medicines authorities across 17 African countries, audited suppliers and manufacturing sites for industry, and guided products through complex registration pathways.
On site against ISO 9001 standards for WAHO
In our comprehensive regional pharmaceutical study
Following our roadmaps and capacity training
By a European pharma client via our AI/automation roadmap
We evaluate your current quality architecture, design costed roadmaps to ISO 9001:2015 readiness, and deliver hands-on training to build internal institutional capability.
Independent GMP, GDP, GCP, and QC laboratory audits of your sites, suppliers, and clinical supply vendors, alongside preparation for stringent regulatory inspections.
Multi-country institutional assessments, end-of-project programme evaluations, and sector-wide manufacturing mapping for regulators, regional bodies, and funders.
Strategic guidance, CTD dossier support, lifecycle management, and product registration, including specialised pathways for Nigeria (NAFDAC/SON) and broader African markets.
Process mapping for complex CMC and regulatory workflows, identifying automation opportunities that eliminate delay, reduce manual error, and retain institutional knowledge.
You need an independent, objective assessment of how your authority or programme measures up, alongside a practical roadmap to close compliance gaps. We have assessed 17 national medicines regulatory authorities for the West African Health Organisation (WAHO) and appraised a World Bank-funded harmonisation programme spanning 15 countries.
You need a robust quality system that satisfies the MHRA, EMA, US FDA, or WHO, suppliers you can rely on, and a clear, efficient route to market registration. Our consultants have led quality and regulatory functions inside global pharmaceutical companies and inspected commercial plants on behalf of national regulators.
You need rigorous, actionable evidence—whether an industry sector study, a multi-country programme evaluation, or an institutional readiness assessment—delivered in English and French by experts who understand regional health institutions. Our assignments for WAHO and the ECOWAS Commission have covered every ECOWAS member state.
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.
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.
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.
BethAri is led by Dr Chinedu Madichie, a Chartered Chemist and CQI/IRCA Lead Auditor for GMP and ISO 9001. His 25+ year career includes executive quality roles at GSK, UCB, PPD, and Haleon, with more than 50 regulatory interactions and inspections completed without a critical finding.
Dr Madichie works alongside former senior officials from the national medicines regulators of Ghana and Nigeria, supported by an international network of specialists in global regulatory affairs, analytical chemistry, laboratory quality, pharmaceutical policy, and vaccine safety. We bring together the exact disciplines required for each assignment.
Registered office in Norfolk. We have diagnosed compliance gaps for global consumer healthcare businesses, harmonised multi-site international SOPs, and conducted clinical supply vendor audits for UK research organisations.
We advise pharmaceutical businesses on regulatory workflow optimisation and process improvement, drawing on senior executive leadership experience in Belgium, Ireland, and Germany.
Operating from our Enugu office in Nigeria with consultants resident across West Africa, we have delivered on-site assignments in 17 African countries in both English and French.
We review available documentation, engage key stakeholders, and rigorously evaluate compliance and operational gaps. We then co-develop tailored recommendations and implementation roadmaps that reflect your objectives, resources, and operating environment. Our approach combines technical rigor, transparent reporting, and collaborative planning to help your organisation move forward with confidence.
We review available documentation.
We engage key stakeholders.
We rigorously evaluate compliance and operational gaps.
We co-develop tailored recommendations and implementation roadmaps that reflect your objectives, resources, and operating environment.
Whether you are preparing for ISO certification, planning a supplier audit, registering a product, or commissioning a regional sector study, your first conversation is directly with a senior consultant.
