Why Jeff Yuen & Associates, Inc.?
We Strive to be a Value Added Partner
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.
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 clients 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.