You rely on commercial manufacturing sites, contract laboratories, suppliers, or clinical supply vendors whose regulatory compliance you cannot independently verify. Alternatively, an inspection by the MHRA, EMA, US FDA, WHO, or a national regulator is imminent, and you need to identify critical compliance gaps before inspectors arrive.
Independent GMP, GDP, GCP, and GLP audits of commercial manufacturing facilities, distributors, warehouses, and clinical trial supply vendors.
Comprehensive audit planning, on-site execution, detailed reporting, and CAPA response reviews.
Gap analysis and simulated regulatory inspections to prepare staff and refine documentation handling.
Design of supplier segmentation frameworks, Quality Agreements, and ongoing performance review metrics.
Specialist auditing of Quality Control (QC) and analytical development laboratories against GLP, data integrity, and compendial expectations:
Basic and advanced GxP training for manufacturing and warehouse personnel, GDP training for distributors, and auditing skills workshops for inspectors and internal audit teams.
Requalification compliance audit of an investigational medicines distribution vendor for a UK clinical research organization.
Advanced GMP training for senior pharmaceutical executives and regulatory inspectors, alongside joint industry workshops.
QMS assessments of 17 national regulators evaluated each authority’s institutional capacity to execute GMP inspections.
Led by Dr Chinedu Madichie (CQI/IRCA Certified GMP Lead Auditor; 20+ global audits annually at PPD; 50+ inspections supported without a critical finding), Mr Bolarinwa Yusuf (led NAFDAC overseas/local GMP inspections across three continents), and Mr Benjamin Botwe (led 20+ manufacturer inspections for Ghana FDA). Laboratory audits draw on Lance Smallshaw (45 years of analytical QC, method validation, stability, and pharmacopoeial affairs leadership).
