Quality & Compliance

Many organizations treat quality as a cost, a necessary overhead to satisfy regulators. PLG’s Quality & Compliance practice treats it as a performance driver. Our team builds quality systems that not only pass inspections but also reduce deviations, accelerate batch release, and give your program the operational reliability that supports timely approval. 

• GxP Quality Strategy, Governance, and interim Head of Quality 
• Quality by Design and product robustness programs 
• Quality Systems & Compliance: SOP development, gap assessments, CAPA management 
• Pre-Approval Inspection (PAI) readiness and mock inspection programs 
• Supplier qualification and audit programs 
• Digital QMS implementation and validation 
• Quality-Driven Supply Chain continuity frameworks 

• 20-30% reduction in recurring deviations through digitalization 
• 20% improvement in equipment availability 
• Faster CAPA closure, QP release, and regulatory approval cycles 
• Reduced product shortage risk through proactive supply chain quality programs 
• Successful PAI outcomes across FDA and EMA inspections 

A failed inspection. A recurring deviation. A supplier quality issue that stops production. Any of these can undo months of work and cost millions. You need quality systems that do more than just meet requirements. They should help you spot problems early, avoid delays, and show regulators your operation is prepared. 

We do more than audit your quality systems. We build, validate, and improve them. Our team of scientists, engineers, and quality experts lead in the areas that matter most: GxP strategy, quality by design, compliance, engineering and operations, supply chain stability, and digital transformation. With our Quality Readiness Index (QRI), we help you shift from reacting to problems to building reliable, proactive quality that regulators trust and your business relies on. 

Your needs change over time, and our solutions grow with you. If you are an early-stage biotech, we help you get ready for inspections and can step in as interim Head of Quality when needed. For small pharma companies, we align your systems, fix gaps, and make sure you are ready for regulators. For mid-to-large pharma, we streamline global operations and build the flexibility your portfolio needs. 

You can measure the results: a 20–30% drop in recurring deviations with digital tools, 20% better equipment availability, lower risk of product shortages, and faster CAPA closure, QP release, and regulatory approvals. 

From pre-approval inspection (PAI) readiness and CAPA remediation to supplier qualification, digital QMS setup, and full audit preparation. We deliver the regulatory accuracy, operational excellence, and digital tools that make quality sustainable, reliable, and ready for regulators.