What We Do
QMS Implementation
- Policy & Procedure Development
- SOP & Work Instruction Writing
- Training Program Design & Delivery
- eQMS Selection, Configuration & Implementation
- Management Review Planning & Facilitation
Auditing & Assessments
- Audit Program Development
- Internal Quality Audits (ISO, FDA, GMP)
- Process & System Audits
- Supplier Qualification & Supplier Audits
- External / Regulatory / Notified Body Audit Readiness
Regulatory & Compliance
- ISO & MDSAP Certification Preparation
- Compliance Gap Assessments
- Cleanroom & GMP Compliance
- Supplier Quality & Vendor Management
- Risk Management Implementation
Organizational Development
- Quality Culture Building
- Change Management & Engagement
- Leadership Coaching in Quality & Compliance
- Cross Functional Team Alignment
- Strategic Planning for Long-Term Resilience
Continuous Improvement
- CI Tools & Workshops
- Root Cause Analysis & CAPA Management
- Process Mapping & Standardization
- KPI Development & Performance Dashboards
- Efficiency Cost Reduction & Waste Elimination
On-Demand Quality Coverage
We can step in as an extension of your quality team to keep daily operations running while you hire, scale, or tackle critical projects. CAPAs, equipment programs, change controls, and more — we’ve got you covered.
Service Packages
Intro
Free
A no-obligation conversation to understand your needs and determine the right level of support for your organization.
Ideal for companies exploring quality improvements, new QMS builds, upcoming audits, or resource gaps. Use this session to ask questions, identify challenges, and get clarity on your next steps.
Hourly Consulting
$55-265
▪ Audit prep, supplier oversight, and compliance readiness
▪ SOP creation, document control, and overall QMS upkeep
▪ CAPAs, change controls, deviations, and equipment program management
▪ On-demand quality leadership, operational support, and team training
fixed-fee packages
Flat Fee
Individual Process Optimization:
▪ SOP Harmonization
▪ Process Design & Audits
▪ Staff Training
QMS GAP Analysis & Roadmap:
▪ Assessment vs. Industry standards/regulations
▪ Prioritized Roadmap
Supplier Qualification Package:
▪ Audit & Risk Assessment
▪ Approved Supplier File Set-up
Audit Readiness Package:
▪ Documentation Review
▪ Mock Audit
▪ CAPA Plan
product bundles
Various
eQMS Selection & Implementation Support:
▪ Vendor Comparison
▪ Implementation Playbook
▪ User Training
▪ eQMS Change Control Management
CAPA Accelerator:
▪ Risk-based CAPA Closure Support with
Templates, Dashboards, and Training
KPI & Dashboard Module:
▪ Standardized Metrics Package tailored for
leadership reporting
QI Evolved 