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.)
- Post Approval Activities
- Compliance Remediation