ENQUAL supports medical device, combination product, and pharmaceutical organizations facing regulatory pressure, design control complexity, or inspection risk.
Our work begins with disciplined discovery—not sales pitches, generic proposals, or premature commitments.
Before preparing any proposal, scope, or pricing, ENQUAL requires completion of a Discovery Intake.
Regulators expect leadership awareness, risk-based prioritization, and clear ownership of remediation logic. Discovery ensures engagement decisions are credible, defensible, and inspection-aware.
· VP / Head of Quality
· Regulatory Affairs leadership
· R&D and Product Development leaders
· Operations and Engineering executives
· Executive or board-level sponsors facing inspection exposure
ENQUAL operates as an extension of quality and engineering leadership, focused on regulatory credibility, risk containment, and durable systems.
Discovery clarifies regulatory context, inspection posture, where real risk resides, and whether ENQUAL is the right partner—before any scope or pricing discussion.
The Discovery Discussion is a structured, executive-level discussion focused on fit, risk, and readiness—not selling.
This is not consulting advice. It is a disciplined assessment of whether and how ENQUAL can materially reduce regulatory or business risk.
· Organizational and product context
· Applicable regulatory frameworks and enforcement exposure
· Quality system pressure points (Design Controls, Risk, CAPA, V&V, Suppliers)
· Inspection and business risk over the next 6–12 months
· Objectives for potential external support
Outcomes may include confirmation that no external support is required, a targeted technical follow-up discussion, an executive-ready exploratory summary, or development of a Statement of Work—only if appropriate.
No pricing or commitments are made without completed discovery.