About This Expert

Nag is an independent GMP/GDP Quality Consultant and Lead Auditor with over 17 years of experience in the pharmaceutical and medical device industries. He specialises in GMP, GDP, API, sterile manufacturing, and medical device quality systems, with extensive experience conducting supplier qualification, contract manufacturing, and distribution audits across Europe, North America, and Asia. Over the last 18 months, Nag has successfully completed more than 40 GMP/GDP audits, and more than 100 audits over the past seven years, covering API manufacturers, finished pharmaceutical manufacturers, medical device companies, laboratories, packaging suppliers, and logistics providers. He has extensive expertise in EU GMP, ICH Q7, GDP, ISO 9001, and ISO 13485, with a strong focus on quality management systems, supplier qualification, process and cleaning validation, data integrity, aseptic manufacturing, change control, CAPA, and regulatory compliance. As a freelance consultant, Nag provides independent third-party audits, supplier qualification, quality system improvement, regulatory compliance support, and comprehensive audit reporting, helping clients strengthen compliance and maintain inspection readiness.

Certifications