Jeff Yuen & Associates
Jeff Yuen & Associates, Inc. is a premier consulting firm specializing in quality, regulatory, and compliance services for the pharmaceutical, biologics, biotech, medical device, and diagnostics industries. With over 32 years of industry experience, the company provides comprehensive services including audits, inspections, validation, project management, regulatory support, and expert consulting. The firm boasts a team of industry veterans, former FDA officials, and subject matter experts dedicated to helping clients achieve compliance and operational excellence. Their mission is to deliver pragmatic, patient-centric solutions that foster a culture of quality and continuous improvement across the life sciences sector, supporting all phases of development from GLP, GCP, GMP to post-market activities.
Industries
Nr. of Employees
small (1-50)
Jeff Yuen & Associates
Orange, California, United States, North America
Services
Third-party and internal audits, mock inspections, and inspection readiness support for GxP areas including GLP/GCP/GMP and combination products.
Qualification and validation support for facilities, utilities and equipment, including commissioning and PQ/OQ/IQ activities.
CSV services, Part 11 assessments, data governance and remediation of data integrity issues, including validation planning for MES and cloud-hosted GxP systems.
Development and review of SOPs, technical documents and regulatory dossiers to support compliance and filings.
Program oversight and coordination of cross-functional activities across development, scale-up, validation and regulatory milestones.
Planning and execution of smoke studies and contamination control assessments to analyze airflow and contamination risk in controlled environments.
Third-party and internal audits, mock inspections, and inspection readiness support for GxP areas including GLP/GCP/GMP and combination products.
Qualification and validation support for facilities, utilities and equipment, including commissioning and PQ/OQ/IQ activities.
CSV services, Part 11 assessments, data governance and remediation of data integrity issues, including validation planning for MES and cloud-hosted GxP systems.
Development and review of SOPs, technical documents and regulatory dossiers to support compliance and filings.
Program oversight and coordination of cross-functional activities across development, scale-up, validation and regulatory milestones.
Planning and execution of smoke studies and contamination control assessments to analyze airflow and contamination risk in controlled environments.
Expertise Areas
- Regulatory inspection readiness and remediation
- Quality management system architecture and remediation (QMS)
- Aseptic processing, sterility assurance and contamination control
- CMC analytics and QC for biologics and cell/gene therapies
Key Technologies
- Airflow visualization (smoke studies)
- Media-fill and aseptic process simulations
- Environmental monitoring program design and risk-based EM
- Analytical method development, qualification and transfer
News & Updates
Participation in foreign inspections and regulatory engagements.
Leadership in pre-approval and drug team management at FDA.
Participation in foreign inspections and regulatory engagements.
Leadership in pre-approval and drug team management at FDA.