Jeff Yuen & Associates, Inc. (JYA) is a well-respected domestic and international consulting firm comprised of former regulators and industry experts. JYA is deeply rooted with an appreciation for regulatory compliance. This fundamental appreciation is balanced with industry expertise to ensure that pragmatic and practical solutions are proposed to our customers and clients.

JYA is well-known for its regulatory and cGMP support required to successfully bring both new and innovative large molecule (biologics) and small molecule products to market. JYA has experience in supporting all phases of clinical and commercial production. Having worked closely with CDER, CVM and CBER colleagues through the years, JYA has established a vast network of contacts inside and outside of the Agency.

JYA also has experienced associates who are QP qualified living in Europe to support EU or EMEA regulatory inspection preparation activities. As well, JYA is capable of supporting a customer's or client's regulatory needs. Senior associates with working knowledge and project management capabilities are available to support virtual companies with respect to staffing of key quality assurance and regulatory affairs functions.

JYA continues to support all types of inspection preparation or audit needs (e.g., GLP, GCP and GMP). In addition, JYA has developed extensive experience in various regions of the world such as Europe, Asia, (India, China, Korea, Taiwan), Australia, Mexico and South America.

Our Values

Patient Safety
Regulatory Compliance
Client Satisfaction

Contact Us

Phone: 714 234-8430
Email: jyuen@jeffyuen.com