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From Exception to Action: Risk-Based Issue Elevation
Under FDA’s Quality Management System Regulation (QMSR), exception handling is no longer about closing deviations—it is about demonstrating risk-based thinking across the product lifecycle. This expectation applies equally to pharmaceuticals, medical devices, and combination products, where disconnected investigations often delay…
Read More2025 FDA 483 Review: Why Combination Products Are Disproportionately at Risk
Combination products sit at the intersection of drug CGMPs, device QSR/QSMR, and Part 4 integration requirements. FDA 483 data across both sectors show that organizations continue to manage these requirements in parallel rather than within an integrated quality system, a…
Read MoreFrom Checklists to Common Sense:How ICH GCP E6(R3) and QSMR Finally Made Quality Grow Up
For years, “quality” in clinical research and regulated product development has had an identity problem. It was often confused with: If it felt like quality was something you survived rather than used, you weren’t wrong. Enter ICH GCP E6(R3) and…
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