ENQUAL is a regulatory and quality consulting firm focused on helping leadership teams make defensible decisions under regulatory scrutiny.
We work with medical device, combination product, and pharmaceutical organizations where quality systems, design controls, or regulatory posture directly affect inspection outcomes, business continuity, or patient risk. Our role is not to execute tasks in isolation, but to support leadership in understanding where risk truly sits and how it should be governed.
ENQUAL was built around a simple principle: regulatory outcomes are driven by decisions, not documents. Documentation matters, but only when it reflects clear ownership, risk awareness, and disciplined prioritization. We help organizations align their systems, actions, and narratives to regulatory expectations in a way that withstands inspection.
We engage directly with senior quality, regulatory, engineering, and executive stakeholders. Our work emphasizes inspection credibility, decision logic, and long-term system durability over short-term fixes or surface-level compliance.
Our engagements are structured to ensure regulatory credibility, clear risk ownership, and decisions that withstand inspection. Every engagement starts with structured discovery to understand regulatory context, inspection exposure, and decision constraints before any recommendations are made. This ensures our work is appropriate, defensible, and aligned to each organization’s regulatory reality.
