Quality Consultation For the Pharmaceutical & Biologics Industries

Our team at Jeff Yuen & Associates, Inc provides the highest quality service for all pharmaceutical phases including pre-clinical, clinical and commercial operations, testing and regulatory support. Find Your Solution
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JYA associates average more than 30 years of industry experience.
%
Our Health Authority professionals (FDA, MHRA, etc) average more than 20 years of experience at their respective health authority prior to joining industry or JYA
%
The cumulative years of experience of our team exceeds 2000 years of total experience.
%
The cumulative health authority/regulator experience exceeds 350 years of time working inside the relevant health authority.
We Strive to be a Value Added Partner

Why Jeff Yuen & Associates, Inc.?

We understand the importance of being collaborative, progressive and pragmatic as a partner. Transparency is critical when it comes to establishing trust and long lasting value-added relationships. Established in 1998, JYA works closely with clients and their CMOs, CROs, CTLs to ensure sites and subject matter experts are well-prepared for mission-critical regulatory inspections.
It is important to ensure that client engagements are properly executed and that customers remain satisfied at all times. JYA is not afraid to "course correct" whenever needed. It is also important to emphasize that JYA does not promote or accept assignments where we cannot bring the proper subject matter experts to the client.
We Strive to be a Value Added Partner

Why Jeff Yuen & Associates, Inc.?

We understand the importance of being collaborative, progressive and pragmatic as a partner. Transparency is critical when it comes to establishing trust and long lasting value-added relationships. Established in 1998, JYA works closely with clients and their CMOs, CROs, CTLs to ensure sites and subject matter experts are well-prepared for mission-critical regulatory inspections.
It is important to ensure that client engagements are properly executed and that customers remain satisfied at all times. JYA is not afraid to "course correct" whenever needed. It is also important to emphasize that JYA does not promote or accept assignments where we cannot bring the proper subject matter experts to the client.

Industry and Health Authority Experience

30 +
Industry Experience Years
2000 +
Cumulative Industry Years
20 +
Staff Health Authority Average Years
350
Cumulative Health Authority Years
12 +
Cumulative Years of Experience
100 %
Industry Experience
100 %
Regulatory Experience
100 %
Total Experience
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Audits and mock inspections prior to an FDA PAI or PLI inspection are critical to understanding risks and managing compliance risks.  Proper Sponsor oversight is mandatory from a regulatory compliance and business continuity perspective.   JYA provides audit support particularly where and when an outsourced model makes sense.  Dependent on the “client’s” procedures, we are capable of scheduling and performing audits including review of acceptability of audit responses.  Our goal is to keep senior management informed of deficiencies and/or potential regulatory findings  (FDA 483s or further regulatory actions: Warning Letters, etc.) and the suitability and timeliness of CAPAs taken to address gaps or deficiencies after completion of the audit.  NOTE:  JYA covers all GXP areas: GLP, GCP, GMP, Combo Products, etc.

Finally, our compliment of industry and former FDA experts have successfully worked on NDA, BLA, ANDA, PMA, and 510k submissions. Our Medical Device Team supports clients with their RA and CMC needs Our combination products experts continue to support regulatory submissions and site inspection readiness activities. Recent court decisions have also required that a number of our pharma clients prepare for medical device inspections.
We remain an idea partner because of our capabilities with respect to electronic filings; continues to work assisting with Drug Registration and Listing (FDA portal) support. As needed, our RA team can even support clients as their listed US Agent to ensure prompt and proper communications with the Agency.
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About COMPANY

Who We Are

CDR Jeff Yuen is a well-respected domestic and international speaker with over 32 years of compliance and regulatory experience; Jeff was a peace officer/investigator with the State of California, Food and Drug Branch and a Consumer Safety Officer for the US FDA. During his tenure with the US FDA, he was rapidly promoted to the rank of Commander in the US Public Health Service while serving as a member of the following teams:

FDA’s Pacific Regional Biotech Team (pre-cursor to ORA Team Biologics)

Foreign Inspection Cadre

Los Angeles District Pre-Approval Manager and Drug Team Leader

12 +
Cumulative Years
of Experience
100 %
Regulatory Experience
100 %
Industry Experience
100 %
Total Experience
12 +
Cumulative Years
of Experience
100 %
Regulatory Experience
100 %
Total Experience
100 %
Industry Experience
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