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Home | Jeff Yuen & Associates

Jeff Yuen & associates has expertise in facility design, construction and inspection for companies performing GMP manufacturing and GCP testing for pharmaceutical and biotechnology products.

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Home | Jeff Yuen & Associates | jeffyuen.com Reviews

https://jeffyuen.com

Jeff Yuen & associates has expertise in facility design, construction and inspection for companies performing GMP manufacturing and GCP testing for pharmaceutical and biotechnology products.

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Facility Mock Inspections | Jeff Yuen & Associates

http://www.jeffyuen.com//services/facility_inspections.php

Sterility Assurance CMC Review. Mock Inspections allow your drug product or device manufacturing facility to be prepared for an anticipated upcoming regulatory inspection by undergoing the rigors and scrutiny of a "live fire" experience. Jeff Yuen and Associates, Inc. 2011 jyuen@jeffyuen.com.

2

GLP | Jeff Yuen & Associates

http://www.jeffyuen.com//services/GLP.php

Sterility Assurance CMC Review. Good Laboratory Practice is the cornerstone of good science. Adherence to GLP principles sets your study above reproach or doubt. Maintaining high standards of adherence is essential to acquiring the necessary data to support your new drug application in the most efficient time frame possible. Jeff Yuen and Associates offers GLP auditing services for preclinical safety studies, viral clearance studies and more. Jeff Yuen and Associates, Inc. 2011 jyuen@jeffyuen.com.

3

Founder Bio | Jeff Yuen & Associates

http://www.jeffyuen.com//corporate/jeff_yuen_bio.php

Sterility Assurance CMC Review. FDA's Pacific Regional Biotech Team (pre-cursor to ORA Team Biologics). Los Angeles District Pre-Approval Manager and Drug Team Leader. Public Health Service Awards and Recognition. PHS Commendation and Achievement Medals - 1998. Recipient ORA/FDA Team Award of Merit - 1998. Vice President Al Gore's Nat'l Performance Review Hammer Award - 1996. PHS Commendation and Achievement Medals - 1995. FDA Investigator of the Year Candidate - 1995. Unit Commendation Medal - 1995.

4

Technical Project Management | Jeff Yuen & Associates

http://www.jeffyuen.com//services/technical_project_management.php

Sterility Assurance CMC Review. Frequently, our clients are facing multiple challenges involved with launching a new product on an accelerated timeline without sufficiently trained staff dedicated to Project Management activities. This is especially problematic in the highly regulated pharmaceutical industry where the project completion can be severely delayed by critical oversight in a single key system. Our Technical Project Management approach is also highly effective at coordinating the evaluation an...

5

Regulatory Submissions | Jeff Yuen & Associates

http://www.jeffyuen.com//services/regulatory_submissions.php

Sterility Assurance CMC Review. Jeff Yuen and Associates offers a full range of regulatory submissions audits for companies desiring to have a pre-submission review, or with negative FDA findings, an audit to assess the validity of data and information. The audit includes review of a pre-submission application or an original application, with all amendments, supplements and annual reports. The application audit encompasses a complete review of:. Current Master Batch Records. A submission audit is benefic...

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redlotuspharma.com redlotuspharma.com

RedLotus Pharmtech Pvt. Ltd.

http://www.redlotuspharma.com/partners.php

QA and GMP Compliance. Supply Chain and Sourcing. We maintain world-class excellence in all aspects of pharmaceutical quality. QA and GMP Compliance. Supply Chain and Sourcing. Jeff Yuen and Associates, Inc. (JYA). Jeff Yuen and Associates, Inc. (JYA) is a well-respected USA based consulting firm comprised of former regulators and industry experts. JYA is deeply rooted with an appreciation for regulatory compliance. Shubhjyot Consulting Engineers Pvt. Ltd. Three S Consulting (3S). 91) 993 091 2577.

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Home | Jeff Yuen & Associates

Sterility Assurance CMC Review. Jeff Yuen and 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 continues to support all types of inspection preparation or audit needs (e.g., GLP, G...

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