Regulatory & Quality Consulting Packages

I. FOUNDATION COMPLIANCE RETAINER- Price: $1,500 / month

• 6–8 hours/month of QA/RA advisory • Email support (24–48 hr)

• SOP review & foundational compliance guidance

• Initial regulatory pathway consultation

II. GROWTH COMPLIANCE RETAINER- Price: $3,500 / month

• 20 hours/month of dedicated QA/RA support

• Priority executive access

• QMS development & SOP refinement

• Comprehensive gap assessments

• Audit readiness preparation

III. EXECUTIVE QA/RA PARTNERSHIP- Price: $6,500–$7,500 / month

• 40–50 hours/month high-touch consulting

• Weekly leadership alignment meetings

• Full QMS buildout or modernization

• Regulatory submission oversight (FDA, MDR, global)

• Audit participation, remediation & CAPA leadership

IV. À-LA-CARTE EXECUTIVE SERVICES

• Senior QA/RA Advisory: $175–$300/hr

• SOP Development: $400–$800 per SOP

• Regulatory Submissions: Custom Executive Quote

• Audit Support: $250–$350/hr

SPECIALTY: Per Project Pricing

Small to Mid Sized Companies ONLY

-1st time ISO 13485:2016 Certification Readiness

-UDI/FDA Database Alignment

-CAPA Remediation and Training

-Guidelines and Requirements Interpretations and applicability

-Management Review

-Internal Audit Program Implementation

-Literature Reviews

THANK YOU FOR TRUSTING US WITH YOUR QUALITY AND REGULATORY BUSINESS NEEDS.