We provide senior, inspection-facing QA leadership on a fractional or interim basis to support organizations during growth, transition, or regulatory pressure. Our support spans both strategic CQA oversight and hands-on execution, including batch disposition, deviation and CAPA governance, change control, and health authority readiness. Whether filling a temporary Head of QA role, strengthening quality decision-making, or stabilizing operations ahead of critical milestones, we embed quickly and operate as part of your leadership team—without the burden of full-time hires.

We support organizations in preparing new or evolving GMP facilities for clinical and commercial operations. Our services include CQV strategy and oversight, quality integration into facility design and start-up, and readiness for first GMP activities. We work closely with facilities, engineering, manufacturing, MSAT, and EHS teams to ensure documentation, training, validation, and quality governance are aligned and inspection-ready. The result: facilities that are operationally sound, compliant, and ready for regulatory scrutiny.

We design and evolve phase-appropriate Quality Management Systems that support development, scale-up, and long-term operations. Our work covers foundational GMP processes—document control, training, deviations, CAPA, change control, risk management, and validation—as well as QMS upgrades and digital implementations (e.g. Veeva Vault). We act as process owner, change leader, or program manager to ensure systems are not only compliant, but usable, scalable, and inspection-ready.

We help organizations prepare for, respond to, and recover from regulatory inspections with confidence. Our expertise includes FDA Form 483s, EMA and Health Canada observations, and third-party audit findings. We lead root cause analysis, CAPA planning and execution, documentation remediation, and QMS stabilization, while supporting clear and credible communication with regulators. Whether proactive or reactive, our focus is on restoring control, credibility, and sustainable compliance.

We help organizations establish regulatory-defensible data integrity frameworks aligned with ALCOA+ principles. Our services include record governance, audit trail review, system validation support, and inspection-focused data integrity assessments. Where appropriate, we also support responsible AI integration into quality systems, ensuring transparency, validation, and compliance while enabling future-ready digital operations.

We conduct risk-based GMP audits and gap assessments aligned with FDA, EMA, Health Canada, and PIC/S expectations. Our audits cover QMS effectiveness, facilities and equipment controls, data integrity, training, batch documentation, and supplier oversight. We also support vendor and CDMO quality governance, including qualification audits, technical agreements, and ongoing performance oversight—helping you de-risk your supply chain and maintain regulatory control.

We design and deliver targeted GMP and quality leadership training that strengthens accountability, decision-making, and quality culture. From investigation excellence to risk-based thinking and inspection preparedness, our programs are practical, role-based, and aligned with current regulatory expectations—helping quality become a lived practice, not just a function.