Paul Dexter

Senior Consultant, GxPAssure

Paul Dexter, MSc (Microbiology) is a senior consultant and former U.S. Public Health Service Captain with 21 years of regulatory and product-quality experience across human and animal drug products. He specialises in drug product quality and microbiology, with deep experience in sterile and non-sterile manufacturing, CMC, pharmaceutical compounding, and cGMP compliance. He has led scientific review teams, advised manufacturers on FDA/EU inspection readiness, and supported responses to regulatory enforcement actions.

Paul’s key areas of expertise:

• Drug product quality & microbiology: Sterility assurance, contamination control concepts, microbiological risk assessment, and quality decision-making.
• Sterile & non-sterile manufacturing: Practical insight into facility and process expectations, including aseptic filling operations.
• CMC and regulatory submissions: Quality review experience across INDs, NDAs, ANDAs, and DMFs; assessment of manufacturing processes and controls.

• cGMP compliance: Deep knowledge of U.S. regulatory requirements, including 21 CFR Parts 210/211, 212, and 312; inspection readiness and compliance strategy.
• Inspection and enforcement response: Supports organisations addressing Form 483 observations, Untitled Letters, Warning Letters, and broader compliance actions.
• Pharmaceutical compounding: Policy and compliance strategy; working knowledge of FD&C Act provisions (503A/503B) and USP standards (USP <795>/<797>).
• Combination products: Cross-centre perspective spanning CDER, CDRH, and CBER considerations.
• Leadership & stakeholder management: Team leadership (including six-person review/strategy teams), mentoring, hiring and staff development; engagement with government and external stakeholders.