BethAri is a consortium of senior consultants specialising in quality management, Good Manufacturing and Distribution Practice (GxP), and regulatory compliance for medicines and health products.
We are registered in England and Nigeria, serving clients across the UK, Europe, and Africa.
Firm founded
Incorporated in England
African countries with on-site assessments
ECOWAS member states
Our consultants have spent their careers on both sides of the pharmaceutical regulatory relationship:
Leading global quality, compliance, and regulatory affairs functions within multinational pharmaceutical and biotechnology companies.
Directing departments within national medicines regulatory authorities and inspecting commercial manufacturing facilities across three continents.
Every project is directly led and delivered by senior specialists. We do not pass work down to junior teams.
We partner with organisations seeking to establish rigorous evidence, raise quality standards, and strengthen health systems:
Navigating inspection readiness, QMS implementation, supplier audits, and complex market access pathways.
Conducting institutional gap assessments, building ISO 9001 compliance roadmaps, and training inspectorates.
Delivering multi-country sector studies, programme evaluations, and capacity-strengthening roadmaps.
Optimising analytical methods, facility compliance, technology transfer, and laboratory quality systems.
Founded in 2007 and incorporated in England in 2013, BethAri’s collaboration with regional health bodies dates from 2008, forming our longest-running body of work alongside our commercial industry practice.
Process mapping and AI/automation roadmap for the regulatory variation process of a European pharmaceutical company, delivering over €2m in recurring annual savings.
Requalification audit of an investigational medicines distribution vendor for a UK clinical research organisation.
Mapping, quantification, and review of local pharmaceutical manufacturing across all 15 ECOWAS member states for the ECOWAS Commission.
End-of-project evaluation of the World Bank-funded West African Medicines Regulatory Harmonisation (WA-MRH) project for WAHO.
Quality gap analysis, CAPA closure, and global SOP harmonisation across UK, European, and Asian sites for a global consumer healthcare company.
ISO 9001:2015 roadmap validation workshops and training for all 15 ECOWAS medicines regulatory authorities in Lagos.
On-site QMS assessments of 10 national medicines regulators in West and Central Africa for WAHO.
On-site QMS assessments of 7 national medicines regulators in West Africa for WAHO.
Authorship contribution to the ECOWAS Regional Pharmaceutical Plan and joint GMP training for NAFDAC and Nigerian manufacturers.
Capacity training for senior NAFDAC assessors on evaluating Module 3 (Quality) of registration dossiers in Abuja.
Joint Good Manufacturing Practice training for pharmaceutical industry executives and regulatory inspectors in Lagos.
BethAri established to provide high-level quality and regulatory consulting.
We examine the full operational picture and co-develop solutions with the teams responsible for running them. The same four-stage methodology applies whether advising a national regulator or a commercial manufacturing site:
We conduct on-site evaluations against international standards through structured interviews, facility tours, and deep-dive documentation reviews (e.g., two-day on-site audits per national authority).
We present gap analysis findings in plain terms and build actionable roadmaps specifying clear milestones, owners, and realistic timelines, including readiness scoring where comparative baselines are required.
We validate roadmaps directly with operational owners, facilitating workshops and delivering targeted training on regulatory requirements to ensure internal ownership.
We audit implementation progress, support corrective action (CAPA) closure, and conduct mock inspections to prepare organisations for formal certification or regulatory audit.
Our work is benchmarked directly against the international standards and regulatory frameworks our clients are audited against:
ISO 9001:2015, ICH Q10 (Pharmaceutical Quality System), ISO 31000, and ICH Q9 (Quality Risk Management).
Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
European Medicines Agency (EMA), UK MHRA, US FDA, WHO Prequalification, and PIC/S.
Common Technical Document (CTD) format for Module 3 (Quality/CMC) and regional registration dossiers.
Our Managing Director is a CQI/IRCA-certified Lead Auditor for Pharmaceutical GMP Quality Systems and ISO 9001:2015. Senior team members include former agency-wide quality managers and IRCA-registered lead auditors.
BethAri Limited is incorporated in England and Wales (Company No. 8810082) with registered offices in Dereham, Norfolk. UK engagements include global compliance remediation for consumer healthcare and clinical vendor audits for life sciences research organisations.
We advise European pharmaceutical businesses on regulatory change automation, workflow optimization, and inspection readiness, drawing on executive quality leadership experience across Belgium, Ireland, and Germany.
BethAri is registered in Nigeria (RC 836302) with offices in Enugu and administrative presence in Abuja. We have delivered on-site regulatory assessments across 17 countries, including all 15 ECOWAS member states, Mauritania, and Chad.
West Africa’s regulatory landscape operates across English, French, and Portuguese. BethAri maintains resident French-speaking consultants in the region, and our regional assessment reports and capacity workshops are delivered in both English and French.
Led by Dr Chinedu Madichie, BethAri draws on an international network of senior specialists in quality assurance, regulatory affairs, analytical science, and public health policy. We assemble bespoke teams tailored to the exact technical requirements and regional context of each assignment.
