Global Key Solutions

Pharmaceutical companies face increasing regulatory pressure beyond routine inspections. The issuance rate of enforcement actions like FDA 483s and Warning Letters has doubled since 2019. Vigilant monitoring and proactive strategies are essential to stay compliant with shifting regulatory expectations. While regulatory, compliance, and quality data is available, it is often fragmented, outdated, lacks context, and is difficult to synthesize into actionable information. Our proprietary engine unifies regulatory and compliance data across the FDA-regulated landscape, providing searchable and actionable insights for quality, operations, and leadership teams. Built by a team of former FDA reviewers and global quality leaders, our engine contains over charts, documents, and inspection observations and citations, all systematically categorized and continuously updated. A top 10 drug and device manufacturer is using our platform to develop data-driven compliance plans, including preventive strategy, continuous improvements, Root Cause Analysis (RCA), and effective Corrective and Preventive Actions. Our information engine has also been used to prepare for FDA inspections and audits. In 2025, we will add document citation capabilities, which will recommend updates to internal regulatory documents and workflows whenever FDA policies are revised.