QMS design, maintenance, and improvement for GxP-regulated life sciences organizations. We build and strengthen CAPA, deviation, document control, and quality event workflows so they function correctly under FDA inspection, not only in routine operations.
Assess your quality management system against FDA and ICH expectations, then design or improve the procedures, workflows, and records that support it.
Investigation, corrective and preventive action planning, and effectiveness checks that stand up to review.
Deviation, nonconformance, and complaint workflows that are documented, risk-assessed, and closed on time.
Controlled procedures, records, and change workflows that keep the QMS inspection-ready.
Supporting a compliant QMS through audits, warning letter responses, and, where the role calls for it, consent decree oversight.
A growing CDMO adding pharmaceutical clients needs a contract Quality Systems Manager with multi-client GMP experience and validated systems knowledge to build out compliance infrastructure across programs.
A biotech company transitioning from clinical to commercial manufacturing needs a validation lead and quality systems consultant experienced in biologics GMP production environments.
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 quality systems project delivered against defined milestones, such as a QMS assessment, a CAPA program overhaul, or a document control build-out.
A quality systems manager or consultant embedded in your team to add capacity or fill an interim role.
Tell us about the need, its regulatory context, and your systems environment. We will scope the engagement accordingly.