OUR PEOPLE & SPECIALIST NETWORK

Senior practitioners on both sides of medicines regulation.

BethAri’s consultants have held senior leadership posts in international pharmaceutical companies and directed departments within national medicines regulatory authorities.

Between them, our team members have inspected manufacturing facilities, audited clinical supply chains, and evaluated regulatory quality systems across Africa, Europe, Asia, and the Americas.

Senior Leadership Guarantee

Every project is directly managed and delivered by one of the senior practitioners featured below. We do not delegate client work to junior staff.

OUR PEOPLE & SPECIALIST NETWORK

Core leadership consultants

CM

Dr Chinedu Madichie

Managing Director & Lead Consultant

Credentials: PhD, MSc, Executive MBA, CChem MRSC | CQI/IRCA Certified Lead Auditor (GMP Quality Systems & ISO 9001:2015)

PROFILE

Chinedu founded BethAri in 2007 and has directed each of its flagship assignments, including the QMS assessments of 17 national medicines regulatory authorities for WAHO, the West African pharmaceutical manufacturing study for the ECOWAS Commission, and global regulatory automation roadmaps for European pharmaceutical clients.

He brings over 25 years of quality, compliance, and regulatory leadership across pharmaceuticals, biotechnology, and medical devices. He began his career as an analytical scientist at GSK, Biovail, and Boston Scientific—where he designed and established a greenfield GMP Quality Control laboratory—before advancing to executive quality leadership roles at PPD, UCB, and Haleon.

  • Rapid Facility Licensing: Secured a commercial manufacturing license for a new investigational medicines facility within three months of start-up, establishing its QMS and Qualified Person (QP) structure in parallel.
  • Global Audit Execution: Conducted 20+ GMP, GCP, and GDP audits annually while leading a global compliance team at PPD, auditing manufacturing and clinical sites across North America, Latin America, Europe, China, and Singapore.
  • Regulatory Track Record: Supported over 50 regulatory interactions and inspections with the MHRA, EMA, US FDA, and WHO without a single critical finding.
  • Organizational Transformation: Led a global quality transformation across product development and clinical operations, directing a team of over 20 senior professionals.
  • External Supply Governance: Designed corporate supplier oversight for a global healthcare company where approximately 70% of products were manufactured by external CMOs.
  • Quality Management Systems & ISO 9001:2015 readiness
  • GMP/GDP/GCP auditing, supplier qualification & inspection readiness
  • Quality risk management (ICH Q9) & global compliance remediation
  • Institutional capacity assessment & regional health programme evaluation
  • Digital quality, CMC process optimization & AI automation roadmaps
  • PhD & MSc in Analytical Science: University of Hull, UK
  • Executive MBA: University of Bedfordshire, UK
  • BSc (Hons) in Chemistry: Ahmadu Bello University, Nigeria
  • Professional Memberships: Chartered Chemist & Member of the Royal Society of Chemistry (MRSC); Member of the Research Quality Association (RQA); Member of the American Society for Quality (ASQ).
  • Languages: English (native/fluent); French (working proficiency).

BB

Mr Benjamin Botwe

Senior Consultant, Medicines Regulation & Institutional Strengthening

Credentials: B.Pharm (Hons), MSc, MPA | Fellow of the West African Postgraduate College of Pharmacists (FPCPharm) & Ghana College of Pharmacists (FGPC)

PROFILE

Benjamin brings over 25 years of distinguished experience in medicines registration, GMP inspection, and regulatory authority development. At Ghana’s Food and Drugs Board (now FDA Ghana), he served as Deputy Chief Executive, Head of the Drug Evaluation and Registration Division, and Acting Chief Executive. During his tenure, he directed the Board’s international GMP inspection programme, auditing over 20 pharmaceutical manufacturing facilities across Africa, Europe, and Asia. He subsequently served as Rector of the Ghana College of Pharmacists.

Since 2012, Ben has served as a World Bank Short-Term Consultant on medicines regulatory harmonisation across ECOWAS. He has advised the World Health Organization (WHO), the African Union (AU), and the United States Pharmacopeia (USP), contributed to the legal framework establishing the African Medicines Agency (AMA), and helped build or strengthen national regulatory systems in Liberia, Botswana, Rwanda, and Sierra Leone. For BethAri, Ben co-authored the 17-NMRA QMS assessment reports and the ECOWAS regional manufacturing mapping study.

  • Medicines registration, CTD dossier evaluation & regulatory harmonisation
  • Institutional capacity building & national regulatory authority development
  • GMP inspectorate methodology & Quality Control laboratory oversight
  • Regional pharmaceutical policy, legal frameworks & strategic planning
  • Technical regulatory training & multi-country stakeholder engagement
  • MSc in Pharmaceutical Analysis (Quality & Management): University of Strathclyde, UK
  • Master of Public Administration (MPA): Ghana Institute of Management and Public Administration (GIMPA)
  • B.Pharm (Hons): Kwame Nkrumah University of Science and Technology (KNUST), Ghana
  • Fellowships: Fellow of the West African Postgraduate College of Pharmacists; Fellow of the Ghana College of Pharmacists.

BY

Mr Bolarinwa Yusuf

Senior Consultant, Nigeria Regulatory, Quality & GMP Compliance

Credentials: B.Sc Pharmacy | IRCA-Registered Lead Auditor | Nigeria National Quality Award Assessor

PROFILE

Bolarinwa is a pharmacist with over 30 years of comprehensive experience spanning national regulation, commercial pharmaceutical manufacturing, and community pharmacy. At the National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria, he rose to Deputy Director and agency-wide Quality Manager in the Office of the Director General, where he established NAFDAC’s ISO 9001:2015 Quality Management System and directed internal audits across all agency directorates.

Earlier, as Quality Manager in the Drug Evaluation and Research Directorate and Assistant Director in the Establishment Inspection Directorate, Bolarinwa planned and led official GMP inspections of sterile and oral-dosage manufacturing plants across Italy, China, India, Brazil, and Nigeria. He served as NAFDAC’s focal point to the World Health Organization on Substandard and Falsified (SF) Medical Products and co-authored five WHO-sponsored national regulatory guidelines. Prior to NAFDAC, he managed product development, marketing, and national sales for leading Nigerian pharmaceutical firms.

  • NAFDAC regulatory compliance, agency liaison & Nigerian market access
  • GMP inspections for sterile, non-sterile & biological manufacturing plants
  • ISO 9001:2015 QMS design, internal auditing & CAPA management
  • Post-market surveillance, anti-falsification strategies & pharmacovigilance
  • Inspectorate capacity building & regulatory compliance training
  • B.Sc in Pharmacy: Ahmadu Bello University, Nigeria
  • Certifications: IRCA-Registered QMS Lead Auditor; Trained GMP Inspectorate Specialist; Assessor for the Nigeria National Quality Award.
  • Memberships: Member of the Pharmaceutical Society of Nigeria (PSN).

DA

Mr Dele Aiyemowa

Consultant, Product Registration & Market Access (Nigeria)

Credentials: B.Sc | Specialist in Nigerian Regulatory Agency Liaison

PROFILE

Dele has over 20 years of hands-on experience guiding international manufacturers through product registration, commercialisation, marketing, and distribution in Nigeria. Based in Kaduna, Nigeria, he leads BethAri’s local product registration operations and regulatory agency liaison.

He has successfully navigated complex approval pathways for international healthcare, cosmetic, food, and beverage manufacturers from Europe, Asia, and West Africa, securing product licenses and brand protection through NAFDAC, the Standards Organisation of Nigeria (SON), and the Nigerian Trademark Registry.

  • NAFDAC, SON, and Trademark Registry product registration management
  • Importation permits, packaging compliance & regulatory documentation
  • Food, beverage, cosmetic & consumer health product commercialisation
  • Local distributor setup, manufacturer representation & market access
OUR PEOPLE & SPECIALIST NETWORK

Specialist network

Beyond our core leadership team, BethAri draws on an international network of senior independent specialists who join project teams when specific technical depth or regional presence is required.

Global Regulatory Strategy & Executive Advisory

Profile: Senior international regulatory leader with executive experience across global pharmaceutical companies and Contract Research Organizations (CROs).

Expertise: Global regulatory development pathways, CTA/IND filings, CTD dossier oversight, health authority engagement (EMA, FDA, MHRA), pharmacovigilance systems, medical information, and market access strategy. Managed regulatory teams across 48 countries with product approvals secured in over 160 markets.

Analytical Science, QC & Laboratory Quality

Profile: Career analytical scientist, Chartered Chemist, and Qualified Person (QP) trainer based in Belgium with 45 years of experience in small-molecule and biological testing laboratories.

Expertise: Quality Control laboratory auditing, analytical method validation and technology transfer, stability testing programmes, statistical process control (SPC), pharmacopoeial compendial compliance, and out-of-specification (OOS) investigation frameworks.

Pharmaceutical Manufacturing, Industry & Policy

Profile: Senior pharmacist and industrial policy specialist with an MBA and 16 years leading a national pharmaceutical manufacturers’ association in West Africa.

Expertise: Local pharmaceutical manufacturing capacity assessments, facility GMP upgrade roadmaps, industrial policy formulation, supply chain bottleneck analysis, and public-private dialogue between regional manufacturers, ministries, and international development partners.

Francophone Regulatory Systems, Vaccine Safety & Pharmacovigilance

Profile: French-speaking pharmacist based in Burkina Faso with advanced postgraduate training in epidemiology, biostatistics, and health research methods.

Expertise: On-site QMS assessments of national medicines regulatory authorities across francophone West and Central Africa, vaccine safety monitoring, post-marketing pharmacovigilance systems, and delivering bilingual regulatory training in English and French.

Talk to the Senior Consultant Who Will Lead Your Project