Echeazu Ogu

PROF. ECHEAZU OGU, PhD

Pharmaceutical Scientist | Regulatory & Quality Expert | Drug Development Consultant

Prof. Echeazu Ogu is an experienced Pharmaceutical Scientist and Consultant with 30+ years of global experience across drug development, regulatory compliance, quality systems, and data integrity oversight. He has contributed to the development and regulatory approval of more than six medicinal products – including Sustiva®, Stocrin®, and Revia® in addition to early development work leading to the first FDA-approved generic equivalent to the Duragesic® Transdermal Drug Delivery System.

With deep expertise in FDA regulations and ICH guidelines, he served as Faculty at the ICH North American Conference on Setting Specifications for New Drug Substances and Drug Products that produced US and Canadian input into the original ICH Q6A Guideline. He subsequently participated in the ICH 4 Conference in Brussels and later attended FDA / Health Canada Regional ICH Meetings. He served as Faculty Coordinator and trainer for Nigeria’s landmark ICH E6 Good Clinical Practice (GCP) training in 2006, helping establish foundational GCP standards in collaboration with global regulators and industry leaders.

Dr. Ogu has led major quality, compliance, and remediation initiatives across multinational pharmaceutical and medical device organizations. As a Quality Assurance Consultant and Subject Matter Expert, he played a key role in a Global Remediation Quality Program established under a Corporate Integrity Agreement (CIA) with HHS/OIG by a US multinational firm to remedy violations of FDA Regulations by the firm’s Medical Device subsidiary. He reviewed all products manufactured and released by subsidiary’s QA during the prior two-year period, including: raw materials, all QA Releases, external audit findings, CAPAs, an open FDA Warning Letter, and validation of the Sterilization Chamber of their Contract Sterilizing firm. He conducted risk assessment, implemented corrective and preventive actions, verified that all operations met FDA, ISO 13485, and Corporate MDD requirements,  leading to successful resolution of the CIA.

Throughout his career, he has directed complex GMP investigations, resolved product Out-of-Specification (OOS) failures, contributed to product reformulation and relaunch activities, and strengthened manufacturing and quality systems to meet FDA, ISO, and global regulatory standards. An experienced auditor, he has conducted numerous domestic and international GMP and Laboratory Data Integrity audits.

Prof Ogu was a Consultant on a major international site selection and facility design project for solid, liquid, and sterile injectable manufacturing operations, ensuring FDA and WHO GMP compliance, including critical segregation of Beta-Lactam production lines. He participated in a new US Pilot GMP manufacturing facility qualification and handover activities, verifying that the facility  “as-built” was in fact “as designed”, conducted equipment IQ/OQ, enabling the successful handover of the facility from the builder to the owner.

In a prior corporate leadership role, he provided corporateoversight of Laboratory Data integrity and defensibility for Industrial Hygiene Laboratory programs across 42 US andinternational locations, protecting employee health, assuring compliance with corporate policies, and avoiding potential workplace-related injury litigation.

Beyond industry, Dr. Ogu has contributed significantly to regulatory systems strengthening and professional development. As a Consultant to Nigeria’s national drug regulatory authority (NAFDAC), he contributed to laying the foundation that enabled subsequent Agency Leadership to attain WHO Maturity Level 3 status, and recently, full ICH membership. He updated GMP and GCP regulations; trained inspectors and industry professionals;and supported the Agency’s Laboratory ISO certification efforts. He was appointed to the Nigerian Clinical Trial Technical Working Group (2015) to help position Nigeria as a preferred destination for clinical trials.

He has served as a long-standing Technical Peer Reviewer for a U.S. Federal Agency related to Drug Development. He coauthored the ISPE GAMP Good Practice Guide for Validation of Laboratory Computerized Systems. A former member of a CEO’s Senior Leadership Team at one firm, he was Head of Quality for Nigeria and West Africa for another firm, where he significantly improved GMP compliance. A former Educator, he holds a PhD and Master’s degrees in Analytical Chemistry from Saint Louis University. He previously held RAC, CIH, and ROH certifications.