Helping you get it right to keep your company moving forward. Yoh knows compliance.
EXPERIENCED COMPLIANCE SUPPORT
NO RESEARCH, JUST TALENT AND DEVELOPMENT.
Complying with industry standards and regulations but most of all - complying with your demands when you need to support regulatory requirements or remediation of a system. Yoh Knows Compliance and we’re well equipped to support and execute the programs necessary to facilitate change.
Yoh Compliance Services Include:
FDA Remediation Services
Master Planning
Regulatory Interpretation
Meeting w/Regulatory Authorities
Inspection Readiness
Quality System Development and Improvement
Standards Assessments Including Gap Analysis
Supplier Quality Management Program Implementation
Auditing (cGMP, Supplier, Internal, Process)
Document Management System Assessments and Implementations
Investigation and Root Cause Analysis Program Implementation
Quality Risk Management Program Deployment
Quality Management Review Implementation
Regulatory Submissions and Strategy (510k, PMA, NDA, BLA, IND, etc.)
