Interim and program-level leadership for quality, compliance, and validation initiatives, including QA and compliance directors, remediation program leaders, and validation project managers.
Experienced leadership for quality and compliance functions during transitions or growth.
Leading remediation programs against commitments made to the agency.
Managing validation initiatives across quality, IT, and operations.
Coordination between QA, IT, and operations, with an understanding of validation lifecycle dependencies.
Leaders in this area understand the regulatory consequences of schedule slippage when an FDA inspection date or remediation commitment is fixed. Technical project management without GxP context is not a substitute.
A pharmaceutical organization under FDA warning letter needs a compliance lead, a quality systems consultant, and a CSV specialist to support remediation commitments within the agency's required timeline.
A pharmaceutical organization mid-ERP upgrade or revalidation without sufficient internal headcount to manage IQ/OQ/PQ and change control requirements.
A biotech preparing for its first FDA pre-approval inspection needs contract compliance and CSV support, including mock inspections, documentation review, and validated systems and electronic records that meet Part 11 and Annex 11 requirements before the inspection window.
A program led against defined milestones, scope, and reporting to your leadership.
An interim quality, compliance, or validation leader embedded in your organization.
Tell us about the need, its regulatory context, and your systems environment. We will scope the engagement accordingly.