Industries We Serve

Dietary Supplements & Botanicals

For both asset-light virtual manufacturers and established facility operators, navigating FDA requirements shouldn't mean sacrificing profit margins. We design agile systems that protect your brand while optimizing your overhead.

  • FDA cGMP Compliance: Comprehensive implementation and auditing of 21 CFR 111 regulations, ensuring bulletproof foundational SOPs and lot-specific documentation.

  • Supply Chain & Sourcing: Precision optimization of global botanical sourcing, ingredient qualification, and Contract Manufacturing Organization (CMO) networks.

  • Clinical Strategy: High-level coordination of clinical collaborations alongside the FDA and top-tier research institutions.

Cosmetics & Personal Care

With new regulatory frameworks reshaping the personal care industry, brand owners carry more liability than ever for what happens inside their contract manufacturing facilities.

  • MoCRA Compliance: Strategic alignment with the Modernization of Cosmetics Regulation Act, implementing robust adverse event reporting and safety substantiation frameworks.

  • Supply Chain Traceability: Building transparent, end-to-end traceability systems that qualify raw material suppliers and protect consumer safety.

Hemp & Cannabis

In a highly fragmented and rapidly shifting regulatory landscape, scaling a botanical extraction brand requires operational discipline. We bring industrial-grade quality control and multi-state regulatory expertise to the hemp and cannabis space.

  • Extraction Lab Optimization: Streamlining extraction processes and facility layouts to maximize yield, safety, and operational efficiency (OE).

  • Track-and-Trace Integration: Seamless, compliant implementation of state-mandated METRC systems to ensure unbroken chain-of-custody reporting.

  • Due Diligence: Rapid facility and compliance auditing for Private Equity acquisitions and M&A evaluations.

Industrial & Engineering Quality

Before applying our methodology to life sciences, the QUOY framework was forged on the technical manufacturing floor. We continue to support advanced industrial operations with rigorous, data-driven quality systems.

  • ISO 9001 Implementation: Designing and maintaining global standard quality management systems that drive continuous process improvement.

  • Technical Compliance: Navigating complex ATEX/IECEX certifications for equipment operating in explosive atmospheres.

  • Root Cause & CAPA: Executing high-level supplier audits and managing complex Corrective and Preventive Action (CAPA) systems to permanently eliminate manufacturing defects.

  • In aerospace and advanced industrial manufacturing, a system failure is catastrophic. We apply that same zero-defect tolerance and mathematical rigor to FDA cGMP and MoCRA compliance. Instead of building bloated, reactive compliance departments, we engineer lean, proactive quality systems. This removes the guesswork, drastically reduces operational waste, and builds highly efficient, audit-ready operations that protect both the consumer and your bottom line.

  • We optimize both, but our leverage points differ for each. For Virtual Manufacturers (brand owners who outsource production), we focus heavily on CMO auditing, strict supplier qualification, and supply chain traceability to protect you from the liabilities you legally hold. For Facility Operators, we focus on floor-level process optimization, ISO/cGMP implementation, and CAPA (Corrective and Preventive Action) management to increase your production margins.

  • The core architecture of a bulletproof quality system is universal. Whether it is the FDA, state cannabis boards, or international ISO auditors, every regulatory body is fundamentally looking for documented control, traceability, and risk mitigation. We build the rigid foundational architecture first, then map the specific regulatory nuances—like MoCRA safety substantiation or METRC track-and-trace—directly onto that framework.

  • Yes. In highly regulated sectors like cannabis, botanicals, and industrial manufacturing, hidden compliance liabilities can destroy an acquisition's value. We conduct rapid, deep-dive compliance and operational audits for M&A targets to identify red flags, assess supply chain health, and map out post-acquisition optimization strategies before the deal closes.