Services : Services

Auditing and Remediation

Client success is our number one priority. Our associates provide unbiased guidance and work with your team to optimize outcomes.

Portfolio of Services

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.

Audits & Gap Assessments

Mock Inspections

Facility Design Reviews

Internal Audits of Quality Units

Qualified Person (UK Based)

Qualification and Validation Review

Due Diligence for Mergers/Acquisitions

Good Documentation Practices an Data Integrity

Training, Coaching and Mentoring

Technical Support & Technical Writing

Regulatory & CMC Support (CDER/CBER)

Data Integrity/Part 11 Assessments and Computer System Validation

Back Room Inspection Management or Support

Vendor/Supplier Qualification Audits

Sterility Assurance and CMC Reviews

Expert Witness

Services : Resources and Tips