FDA, GMP & Quality Consulting Services

Serve as Fractional or Interim Head of Quality, provide executive oversight and help establish practical quality strategy and organizational structure.

Design, implement and remediate phase-appropriate QMS programs. Support deviations, investigations, CAPA, change control, document control, training and management review.

Assess readiness, identify compliance risks, prepare teams and records, conduct mock inspections and support response and remediation activities.

Provide quality oversight for clinical and commercial manufacturing, including batch disposition, lot release, quality agreements, technology transfer, validation and lifecycle quality management.

Qualify and audit CDMOs, CROs, laboratories, API manufacturers, packaging suppliers, warehouses and other outsourced partners; assess and manage supplier risk.

Hands-on quality support for development, manufacturing, commercialization, remediation and other projects that need experienced hands-on Quality leadership.