Regulatory Compliance Setup Package for Brand Owners
FDA Compliance System for Private Label, Co-Manufactured & Imported Products
This program provides a complete, one-time compliance system setup for brand owners who outsource manufacturing but remain responsible for meeting U.S. FDA regulatory requirements, establishing a fully documented, audit-ready framework that covers supply chain controls, product compliance, and optional importer obligations under FSVP in alignment with the Food Safety Modernization Act (FSMA).
Platform Objective
To develop and implement a complete FDA-compliant quality and food safety system for brand owners that:
- • Ensures oversight of co-manufacturers and suppliers
- • Establishes compliant documentation and control systems
- • Supports product traceability, recall readiness, and risk management
- • Aligns with FDA requirements for domestic and imported products
- • Provides audit-ready documentation without ongoing operational burden
Who This Program Is For
- • Brand owners relying on co-manufacturers, private labelers, or contract packers
- • Companies without in-house production facilities but responsible for compliance
- • Importers of food, beverages, or dietary supplements subject to FSVP
- • Businesses preparing for FDA inspections, distributor onboarding, or audits
Scope of Work
A. Supplier & Contract Manufacturer Compliance
- • Development of supplier approval and verification programs aligned with 21 CFR §117.410
- • Supplier evaluation tools, risk scoring, and approval tracking systems
- • Product and packaging specification templates aligned with regulatory requirements
- • Internal audit program for co-manufacturer oversight and performance monitoring
- • Quality agreement templates defining roles, responsibilities, and compliance expectations
- • Food Fraud Vulnerability Assessment (FFVA) aligned with 21 CFR Part 121
- • Record retention and document control systems aligned with 21 CFR §117.315
B. Product Compliance & Risk Management Programs
- • Label and product version control systems to manage regulatory updates
- • Traceability program aligned with 21 CFR §1.1315
- • Product withdrawal and recall program with defined roles and procedures
- • Customer complaint handling and trend analysis system
- • Crisis management procedures for food safety incidents and regulatory events
- • HACCP or Food Safety Plan templates including hazard analysis and control identification
C. Optional FSVP Compliance Setup (For Importers)
- • Development of a compliant Foreign Supplier Verification Program (FSVP) structure
- • Foreign supplier evaluation and risk-based verification tools
- • Emergency supplier approval procedures
- • Food defense assessment tools for foreign suppliers
- • Guidance on FSVP importer responsibilities and registration requirements
Deliverables
- • Customized SOPs and compliance documentation, including:
- • Supplier approval and audit procedures
- • Product specifications and traceability forms
- • Recall and food defense programs
- • HACCP or Food Safety Plan templates
- • Written assurance documentation
- • Supplier evaluation and risk assessment reports with verification summaries
- • Food fraud vulnerability assessment tools and reports
- • Document control systems with version tracking and audit logs
- • Label compliance assessment tools and checklists
- • Training materials with lessons and competency quizzes
- • Optional FSVP compliance program (if applicable)
- • Client collaboration tools, including presentation decks, meeting summaries, and change logs
Implementation Approach
- • Structured documentation development aligned with regulatory requirements
- • Customization based on product type, supplier structure, and operational model
- • Integration of compliance tools into a cohesive system
- • Delivery of audit-ready documentation for immediate use
Ideal For
- • Private label brands and contract manufacturing businesses
- • Importers requiring FSVP-compliant documentation systems
- • Companies launching new products into the U.S. market
- • Businesses needing a turnkey compliance system without ongoing management services
- • Organizations preparing for FDA inspections or retail/distributor requirements
Platform Value
- • Establishes a complete, audit-ready FDA compliance system
- • Provides structured oversight of suppliers and co-manufacturers
- • Reduces regulatory risk for outsourced production models
- • Supports scalability as product lines and suppliers expand
- • Enables rapid readiness for inspections, audits, and customer requirements
Base Package – $99/User/Month
Your digital foundation for U.S. primary production and harvest-level compliance.
Includes:
- • Secure Document Repository
- • Training Tracker & Competency Validation
- • Compliance Alerts Dashboard
- • Qualified Individual Registry
- • Email Support and Guided Onboarding
Included Virtual Support & Coaching
- • On-Demand Access to a Compliance Coach
- • Live Support via Virtual Office Hours
- • Free Software Navigation and Coaching
- • Basic Guidance on Applicable CFRs
One-Time Setup Fee – $2,950.00
Includes a full documentation toolkit tailored to your regulatory framework.
Toolkit Scope (customized by industry):
For Seafood Processors (21 CFR 123):
- • HACCP Plan Builder
- • Sanitation SOPs
- • Critical Control Point Logs
- • Monitoring & Verification Templates
For Aquaculture Operations (50 CFR 622.106):
- • Water Quality Management Logs
- • Feed & Medication Records
- • Biosecurity SOPs
- • Harvest Control Procedures
For Produce Safety Rule (21 CFR 112):
- • Agricultural Water Management Plan
- • Biological Soil Amendments SOPs
- • Worker Health & Hygiene Logs
- • Harvest/Post-Harvest Sanitation Procedures
For GAP/HGAP-Aligned Agriculture Programs:
- • Field Inspection Logs
- • Pest & Disease Monitoring Templates
- • Training Records for Field Workers
- • Traceability Logs
Optional Add-On Modules
Toolkit Scope (customized by industry):
| Add-On Feature | Description | Price/User/Month | Action |
|---|---|---|---|
| Products Management | Manage product specs, labels, packaging, and risk categories | $59 | Subscribe |
| Customer Requirements Management | Track customer-specific compliance documentation | $59 | Subscribe |
| Food Fraud Vulnerability Assessment (FFVA) | Document FFVAs and mitigation actions | $69 | Subscribe |
| HACCP/Food Safety Plan Builder | Guided builder for hazard analysis, preventive controls, and verification logs | $89 | Subscribe |
| CAPA & Non-Conformance Tracker | Log non-conformities and track corrective/preventive actions | $49 | Subscribe |
| Supply Chain Compliance Tracker | Monitor supplier compliance, COAs, and verification activities | $69 | Subscribe |
| Internal Audit Scheduler | Manage audit tasks, follow-ups, and audit team roles | $39 | Subscribe |
| Digital Forms & Logs | Build interactive logs for sanitation, temperature checks, etc. | $99 | Subscribe |
| Environmental Monitoring Logs | Track swab test results and map risk-prone areas | $59 | Subscribe |
| Training Library Access | Preloaded PCQI and FSMA training modules with built-in assessments | $49 | Subscribe |
| Archive Management Module | Securely store, retrieve, and manage expired or historical compliance records | $39 | Subscribe |
| Customization Fee | One-time setup for custom-built digital forms | $300/form | Subscribe |
Bundle all module add-ons for $650/user/month (excluding dashboard expansions and custom digital forms)
Optional Add-On: Compliance Dashboard Expansion
Need to manage specific regulatory frameworks beyond the base system? Add dedicated dashboard hierarchies based on your operation type:
| Compliance Scope | Dashboard Only (Enterprise Rate) |
Dashboard + Templates (Enterprise Rate) |
|---|---|---|
| Seafood HACCP (21 CFR 123) | $69/user/month | $169 per month per facility |
| Aquaculture (50 CFR 622.106) | $69/user/month | $169 per month per facility |
| Produce Safety Rule (21 CFR 112) | $69/user/month | $169 per month per facility |
| GAP/HGAP-Aligned Programs | $69/user/month | $169 per month per facility |
| Custom Scope (e.g., USDA, international standards) | $89/user/month | $169 per month per facility |
Each includes:
- • Dashboard hierarchy mapped to regulatory requirements
- • (Optional) SOPs, checklists, and log templates
Who It Is For
- • U.S. and foreign suppliers subject to FDA Produce Safety Rule
- • Farms, aquaculture operators, and harvesters needing recordkeeping tools
- • Facilities under seafood HACCP requirements
- • GAP/HGAP-certified producers and exporters
- • Operations needing digital oversight of primary production safety programs
Toolkit Scope (customized by industry):
Example Pricing (with Add-Ons + 1 Digital Form)
| Item | Rate |
|---|---|
| Base Package (1 user) | $99/month |
| Add-Ons Bundle (1 user) | $650/month |
| Custom Digital Form (1 form) | $300 |
| One-Time Setup Fee | $2,950 |
| Total/User/Month | $1,049 |
Need Expert PCQI Support?
Partner with our experienced Preventive Controls Qualified Individuals (PCQIs) for practical FDA compliance guidance, documentation support, Food Safety Plan development, regulatory consulting, and ongoing compliance services tailored to your operation.
