Expert Witness

We offer a comprehensive service offering to meet your drug or device compliance needs.

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support@jeffyuen.com

No one wants to be in the situation to need an expert witness, but when you do need one, you can rely on JYA’s team to be in your corner.  Our experts are experienced and provide expert testimony for your distinct situation. 

Experts Associate

Jeff Yuen (exFDA)

Jeff Yuen (exFDA)

Jeff Yuen (exFDA)

Jeff Yuen (exFDA)
Gary Brennan

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.
Gary Brennan
Monique Mendoza

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.
Monique Mendoza
Ken Mhuvich (exFDA) <br> <div class="new">Sr Associate</div>

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.
Ken Mhuvich (exFDA) <br> <div class="new">Sr Associate</div>

Meet Our Team

Gary Brennan (GMP)

Ken Muhvich, Ph.D. (ex-FDA)

Alicia Mozzachio (ex-FDA / GMP)

Marsha Steed (Micro. / Sterility Assurance)

Chris Wubbolt (DI)

Jeff Yuen (ex-FDA / GMP)

Affordable
Cost
Quality
of Work

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