Expert Witness
We offer a comprehensive service offering to meet your drug or device compliance needs.
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Experts Associate
Jeff Yuen (exFDA)
Jeff Yuen (exFDA)
Gary Brennan
Gary Brennan
A seasoned quality executive, Gary has lead quality and compliance organizations for more than 30 years. His experience includes laboratory operations, quality/compliance, and validation oversight for API/Drug Substance and sterile and non-sterile drug product programs. Gary's previous companies include Teva, Mallinckrodt, Alcami (AAI/Cambridge Major Laboratories) and Exela Pharma Sciences.
Monique Mendoza
Monique Mendoza
Monique has over 25 years of experience in the pharmaceutical/biotechnology industry and has worked with many dosage forms including oral solid dose, topicals and injectables. She has worked both domestically and internationally for multi-national companies including Bayer Healthcare, Dynavax Technologies, and Pharmaceutics International Inc. She has a strong technical knowledge of aseptic and API operations and overall knowledge of Quality Systems.
Ken Mhuvich (exFDA)
Sr Associate
Ken Mhuvich (exFDA)
Sr Associate
Ken Muhvich, Ph.D. is a microbiologist with extensive experience helping pharmaceutical and biopharmaceutical facilities establish effective viable microbial contamination control programs. He spent several years at the exFDA and provides advice regarding the exFDA’s expectations for firms manufacturing sterile products. He also aids clients that are investigating microbial contamination events.
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Kevin Martin
- Co Founder
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“Jeff Yuen and his team provided exceptional insights, reliable service and durable results for some of our most complex regulatory and compliance projects across OSD and sterile does forms. Jeff and his team were responsive to emergent needs on a daily and weekly basis. In addition to the highest levels of subject matter expertise, Jeff and his team, integrated themselves with the local teams and provided much needed management maturity and leadership acumen when needed. We would not have been successful without the support of Jeff Yuen and Associates.”
Kurt Nielson
- CEO
Jeff Yuen & Associates, Inc. (JYA) is the premiere and most valuable consulting firm for Quality Consulting in the Pharmaceutical, Biologics, Biotech, and Diagnostics Industries.
While working as a VP, Quality for a medium sized global Biotech Company, Jeff Yuen and his Associates provided excellent Gap Analyses, Mock Inspections, training, guidance, and support for 2.5 years, and this helped to achieve zero observations on an FDA Pre-Approval Inspection (PAI) and an FDA Pharmacovigilance Inspection.
As I networked throughout the Pharma, Biotech, Biologics, and Diagnostics industries and met QA professionals in other successful companies, a common denominator was having JYA as a trusted and valuable consulting company providing world-class support.
John McKay - MS; ASQ CMQ/OE, CQA; Certified Lead Auditor for ISO 9001, ISO 13485, ISO 14001
- President, Chief Quality and Regulatory Affairs Officer Q1 Associates LLC
I feel so privileged to work with and grateful to Jeff Yuen & Associates for always picking up my call and walking with me many incredible quality and GMP compliance journeys across multiple organizations I worked for in the last 15+ years.
When I needed a mentor, an advisor, a book of knowledge, a pragmatic solution to a significant quality event, getting ready for a pre-license or pre-approval inspection, or simply a buddy to laugh with, Jeff Yuen has been my number 1 call!
Jeff & Team, your contributions to our successes, your wisdom and pragmatic approach to solving quality and GMP compliance issues are unmatched. Thank you for your partnership and I wish you continued success supporting our ever growing, complex and dynamic industry.
Georgeta Puscalau
- Sr Vice President Quality
I’ve had the pleasure of working with Jeff and his team for several years. While most of our work has been in the PAI/PLI prep space (mock inspections, storyboard reviews) we’ve also collaborated with Jeff’s team on everything from short-term Quality leadership staffing to guiding facility issue remediation. Jeff’s reputation as a leader in quality & compliance consulting is completely deserved. He and his team were key and trusted parters as we obtained our first FDA approvals.
- Quality Executive for Commercial Gene Therapy Company