Investment: Complimentary

Objective: Alignment and Risk Evaluation

QUOY is a highly deliberate consultancy, and we do not accept all engagements. This initial briefing evaluates operational alignment to ensure your executive team is committed to systemic optimization—not just looking for a scapegoat for existing regulatory failures. We map your current technical debt and determine if our methodologies can yield a quantifiable ROI for your operation.

Investment: Project-Based Flat Fee

Objective: Defensible Market Positioning and Federal Risk Mitigation

When regulatory friction threatens market access, you need a systems architect, not just a consultant. We provide high-stakes intervention to protect your brand’s license to operate and ensure your aggressive marketing claims remain legally defensible.

• FDA Crisis Response: Rapid, highly technical drafting and remediation strategy for FDA Form 483s and Warning Letters.

• Claim & Asset Substantiation: Rigorous evaluation of labels, websites, and marketing collateral to ensure alignment with current FDA and FTC enforcement climates.

Regulatory Roadmapping: Strategic guidance on formulation and market entry to prevent costly recalls or federal liabilities.

Investment: Project-Based Flat Fee

Objective: Overhead Reduction and Operational Velocity

Most legacy compliance systems are paper-heavy, slow, and prone to human error. We modernize your infrastructure into lean, digital environments that accelerate batch release and eliminate the redundant protocols draining your margins.

• Paper-to-Digital Migration: Architecting Part 11-compliant digital systems within your existing Microsoft or Google workspaces, or integrating specialized third-party databases.

• Efficiency Evaluations: Identifying and stripping out "compliance theater"—the bloated SOPs that slow down production without increasing product safety.

Workforce Calibration: Training and optimizing your internal Quality and Regulatory teams to operate with industrial-grade precision and technical accountability.

Investment: Flat Fee per Audit + Advisory Retainer

Objective: Margin Protection and Vendor Accountability

For Asset-Light operations, your Contract Manufacturing Organization (CMO) is a critical vulnerability. We apply rigorous physical and data-driven auditing to ensure your supply chain partners are delivering on quality without eroding your gross margins.

• On-Site Physical Audits: Executive-level inspections of supplier and contract manufacturing facilities.

• Vendor Redundancy Architecture: Sourcing and vetting alternative raw material suppliers and manufacturers to eliminate single points of failure.

Contractual Realization: Ensuring the quality standards dictated in your Quality Agreements (QAs) are actively executed on the production floor.

Investment: Project-Based Flat Fee

Objective: Valuation Accuracy and Acquisition Risk Mitigation

Before acquiring a brand or a manufacturing facility, Private Equity firms and executive boards must understand the target's hidden regulatory debt. QUOY conducts exhaustive pre-acquisition audits of Quality Management Systems, supply chains, and regulatory standing to ensure you are buying a performing asset, not a latent federal liability.

Investment: Premium Monthly Retainer (Capped Availability)

Objective: Fractional Leadership and Operational Continuity

For organizations that have completed a foundational QUOY project, we offer ongoing fractional executive oversight. This tier embeds our systems-based rigor directly into your leadership team, ensuring your optimized infrastructure does not degrade over time. Because this requires deep integration, QUOY strictly limits the number of active retainer partnerships.

• Fractional Quality Executive: Serving on steering committees or advisory boards to guide long-term regulatory strategy and M&A integration.

• Continuous Vendor Monitoring: Ongoing, data-driven oversight of CMOs to catch margin erosion and quality drift before it impacts the P&L.

Priority Crisis Access: Bypassing the project pipeline for immediate, on-demand triage of unexpected regulatory shifts or supply chain disruptions.