Selected Projects

Representative engagements across quality, regulatory, clinical supply, and growth.

QMS for MAH (US & CA)

Set up a Quality Management System for a Marketing Authorization Holder in Switzerland to meet US and Canadian market requirements.

  • Policy and SOP framework
  • Training program and rollout
  • Inspection readiness

ATMPs — GxP Consulting

Supported advanced therapy medicinal products with fit-for-purpose GxP processes across development and supply chain.

Clinical Trial Supply Leadership

Led clinical trial supply services, stabilizing operations and improving service levels across multiple studies.

Inspection Readiness Program

Designed a comprehensive program covering documentation, training, mock inspections, and CAPA management.