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Pricing Plans
Free Insight Access
0$ÂFree access to select insights and introductory resourcesValid for 12 months- Introductory quality risk content
- Community updates
- Sample advisory insights
Regulatory Assessment
7,500$ÂFull-Day Onsite/Virtual Assessment-One-time risk management consultationValid for one month- Objective operational and compliance insight
- Identification of high-risk gaps and vulnerabilities
- Strategic recommendations for improvement
- Increased inspection and audit readiness
- Actionable next steps to support sustainable compliance
Monthly Advisory Retainer
10,000$Every monthOngoing access to enterprise risk advisory services Services provided under retainers are customized based on client needs, industry requirements, organizational risk, and agreed-upon service levels.Valid for 6 months- Operational Excellence Consulting
- Quality & Compliance Advisory
- FDA / ISO Inspection Readiness Support
- CAPA & Remediation Guidance
- Strategic Business Consultation
Rapid Regulatory Assessment
12,500$ÂDesigned for organizations requiring immediate high-level assessment following FDA observations or compliance concerns.Valid for one month- Initial regulatory risk assessment
- Review of FDA observations/findings
- Executive consultation session
- Gap identification & risk prioritization
- Preliminary remediation roadmap
- Immediate containment recommendations
- Regulatory response strategy guidance
FDA 483 Response Support
35,000$ÂComprehensive support for organizations responding to FDA Form 483 observations.Valid for 8 weeks- Detailed observation analysis
- Root cause evaluation support
- CAPA strategy development
- Remediation planning
- Response letter drafting support
- Executive review sessions
- Quality system gap assessments
- Risk-based prioritization strategy
- Action tracking recommendations
Engagement terms subject to master service agreements. Local regulatory fees not included in plan pricing.
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