Food Defense Readiness Review & Gap Identification Services
Powered by Consultare Inc. Group — A Compliance Company
Delivered via the IntelComp Readiness Platform | Supported by Verified Service Providers
Consultare Inc. Group supports food manufacturers, processors, and distributors through Food Defense preparedness activities associated with the FDA’s Food Defense requirements under 21 CFR Part 121 (Intentional Adulteration Rule). All services are supported by Verified Service Providers — experienced food safety professionals and FSMA specialists familiar with Food Defense preparedness concepts, vulnerability assessment methodologies, and mitigation planning considerations. We help organizations identify documentation gaps, review preparedness activities, and support readiness planning associated with Food Defense expectations and GFSI-aligned programs.
PACKAGE 1
Basic Food Defense Readiness Review (Vulnerability Screening)
Ideal For:
-
• Small and medium-sized facilities supporting Food Defense preparedness activities associated with the IA Rule
• Food manufacturers seeking a high-level review of Food Defense documentation
Scope Includes:
-
• Kickoff session and scope alignment discussions (registered facilities or organizations supporting Food Defense preparedness activities)
• High-level review of current Food Defense documentation and mitigation planning activities
• High-level discussion of actionable process steps and vulnerability considerations
• Gap Summary Report and preparedness considerations for future planning
• High-level preparedness action summary
Timeline:
-
• 2–3 Weeks
Estimated Price:
-
$3,500 – $5,000
(Pricing based on site complexity and documentation maturity)
PACKAGE 2
Standard Food Defense Readiness Review (Expanded IA Rule Review
Ideal For:
- • Facilities covered by FDA’s Intentional Adulteration Rule • Organizations seeking expanded documentation and preparedness reviews related to Food Defense activities
Scope Includes:
- • Review of documentation associated with applicable 21 CFR Part 121 provisions • Discussion of key activities (e.g., mixing, batching, secondary packaging) • Review of mitigation planning documentation, preparedness records, and training documentation • Readiness discussions with Food Defense personnel and facility representatives • Structured documentation review findings and detailed Gap Identification Report • Preparedness planning recommendations and documentation roadmap
Timeline:
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• 4–6 Weeks
Estimated Price:
-
$8,500 – $12,500 (Pricing based on site complexity and documentation maturity)
PACKAGE 3
Premium Food Defense Readiness Review & Preparedness Support
Ideal For:
- • FDA-regulated facilities seeking enhanced Food Defense preparedness support • Organizations seeking expanded readiness discussions and documentation guidance
Scope Includes:
- • Comprehensive review of Food Defense documentation associated with the IA Rule • On-site or virtual preparedness walkthrough discussions involving vulnerable process steps • Review of mitigation planning documentation and preparedness records • Inspection preparedness discussions informed by FDA inspection approaches • Food Defense Readiness Summary and Preparedness Planning Roadmap • Executive Management Report • 90-Day Readiness Support Services, including:
- ∘ Food Defense role awareness discussions ∘ Documentation and training discussions ∘ Preparedness documentation guidance
- ∘ Food Defense role awareness discussions ∘ Documentation and training discussions ∘ Preparedness documentation guidance
Timeline:
-
• 6–8 Weeks
Estimated Pricing:
-
$15,000 – $22,000 (Pricing based on site complexity and documentation maturity)
ADD-ON SERVICES (Supported by Verified Food Safety Professionals)
| Service | Description | Fee |
|---|---|---|
| Ongoing Readiness Support Services | Monthly Food Defense preparedness support related to documentation activities and training coordination | Custom Quote |
| Documentation Support Services | Documentation support related to Food Defense Plans, preparedness records, and SOP resources | Custom Quote |
| IntelComp Platform License | Digital platform supporting Food Defense documentation activities and preparedness visibility | Custom Quote |
