ICH Q9 focused Revision Q9 (R1): Poster Presented at PDA Week 2026

A meaningful quality strategy is essential for a pharmaceutical or device company to achieve its strategic objectives. As companies evolve and move through the product development lifecycle, an early understanding of quality risks and gaps is essential to ensure success with regulatory approval, partner due-diligence, and agency audits. Using a unique approach which combines the concepts of Quality Risk Management (QRM) and Quality Management Maturity (QMM) with the FDA Six-Systems model, a strategic quality plan can be developed which identifies and prioritizes the improvement efforts needed to ensure a compliant and efficient approach to quality. This model can be applied to the US, EU and global expectations for compliance at every stage of the product lifecycle.This approach is unique in that it considers the organizational and strategic context of the quality unit when identifying risks and necessary mitigation actions. The result is a holistic action plan aligned with the company's strategic goals which addresses structural and behavioral deficiencies in addition to the technical compliance gaps normally identified during a typical gap assessment process.