Regulatory, Certification, and Valuation Disclaimer
PCQIServices.com is a proprietary Preventive Controls Qualified Individual (PCQI) Compliance Services Platform developed and operated by Consultare Inc. Group to support FSMA Preventive Controls compliance, food safety program implementation, documentation control, audit readiness, and ongoing regulatory oversight.
PCQIServices.com does not certify organizations, does not issue regulatory approvals, and does not replace the legal responsibilities of regulated entities, including food manufacturers, processors, brand owners, importers, animal food facilities, or operators. All references to FDA, FSMA, PCQI, Preventive Controls, HACCP, GFSI, ISO, USDA, and other regulatory or certification frameworks are provided solely to describe service scope, documentation alignment, and compliance-management support, and do not imply certification authority, regulatory approval, or government endorsement.
Use of PCQIServices.com does not guarantee regulatory compliance, inspection outcomes, audit results, or enforcement outcomes. Final compliance determinations, inspection findings, warning letters, and enforcement actions remain the sole responsibility of the U.S. Food and Drug Administration (FDA), USDA (where applicable), certification bodies, and the regulated organization.
PCQIServices.com is designed to support and facilitate:
● FSMA Preventive Controls documentation and recordkeeping
● PCQI-led food safety program development and oversight
● Internal compliance monitoring and FDA inspection readiness
● Evidence organization, verification, and corrective action tracking
but does not act as a regulatory authority, certification body, accreditation entity, or government agency.
Professional Reliance Notice
PCQIServices.com is intended to be used in conjunction with qualified food safety and regulatory professionals, including Preventive Controls Qualified Individuals (PCQIs), FSMA Qualified Individuals, auditors, consultants, and legal advisors, as appropriate.
Valuation Disclaimer
The stated management-estimated market value of PCQIServices.com reflects internal assessments of proprietary regulatory workflows, documentation intellectual property, service scalability, brand positioning, and strategic relevance as of the publication date.
All valuations are estimates only and are provided for informational, strategic, and pre-investment discussion purposes. Final valuation is subject to formal appraisal, financial review, operational and technical due diligence, market conditions, and transaction structure.
No Regulatory Endorsement
References to the FDA, USDA, FSMA, GFSI, ISO, Codex Alimentarius, or other standards bodies and agencies do not imply endorsement, approval, sponsorship, or affiliation.
Publication Date: 20251216
PCQIServices.com
FSMA Preventive Controls & PCQI Compliance Services Platform
A Core Regulatory Services Asset of Consultare Inc. Group
Platform Overview
PCQIServices.com is a specialized FSMA Preventive Controls compliance and PCQI advisory services platform operated by Consultare Inc. Group to support food facilities subject to the Preventive Controls for Human Food and Animal Food rules under the Food Safety Modernization Act (FSMA).
PCQIServices.com functions as the Preventive Controls compliance arm of Consultare Inc. Group’s Remote Virtual Compliance Department, enabling regulated facilities to implement, maintain, and continuously manage food safety plans, hazard analyses, preventive controls, monitoring records, verification activities, and corrective actions in an audit-ready structure.
The platform is purpose-built for environments where Preventive Controls non-compliance results in FDA inspection findings, Form 483 observations, Warning Letters, product recalls, operational shutdowns, and reputational risk.
Core Capabilities
FSMA Preventive Controls Compliance Management
Preventive Controls for Human Food — 21 CFR Part 117
● Hazard analysis and risk evaluation
● Preventive control identification (process, allergen, sanitation, supply-chain)
● Monitoring, verification, and corrective action documentation
● Food safety plan development and maintenance
Preventive Controls for Animal Food — 21 CFR Part 507
● Hazard analysis and preventive controls for animal food operations
● cGMP integration and compliance documentation
● Monitoring and verification record management
PCQI Program Oversight
● PCQI-led food safety plan development and review
● Validation and verification activity documentation
● Annual reanalysis and change management support
● PCQI responsibility and training documentation
HACCP & Risk-Based Program Integration
● HACCP-based hazard analysis alignment
● Integration of HACCP principles within FSMA Preventive Controls frameworks
● Support for multi-program environments (FSMA + GFSI + customer requirements)
Supply-Chain Preventive Controls
● Supplier approval and verification program development
● Review of supplier food safety documentation and certifications
● Corrective action tracking for supply-chain risks
Documentation & Recordkeeping
● Food safety plans, SOPs, monitoring logs, and verification records
● Version control, approval workflows, and controlled access
● Regulatory-aligned record retention and traceability
Audit & Inspection Readiness
● FDA Preventive Controls inspection preparation
● Mock inspections and gap assessments
● Evidence mapping to regulatory requirements
● Historical audit trails supporting inspections and enforcement reviews
Strategic Value
PCQIServices.com is not a general food safety consulting offering.
It is a regulation-driven compliance services platform engineered specifically around FSMA Preventive Controls enforcement, PCQI accountability, and FDA inspection realities.
Its integration with Consultare Inc. Group’s broader compliance ecosystem creates:
● High client retention driven by mandatory regulatory requirements
● Strong switching costs due to embedded food safety documentation history
● Recurring service and subscription-based revenue
Estimated Market Value
PCQIServices.com — FSMA Preventive Controls & PCQI Compliance Platform
Management-Estimated Market Value: $2,600,000
Valuation reflects proprietary regulatory workflows, standardized documentation libraries, recurring compliance service potential, brand specialization, and strategic value within U.S. food import and supply-chain compliance markets. Final valuation subject to formal appraisal and due diligence.
Portfolio Classification
● Asset Type: Regulatory Services Platform
● Primary Use: FSMA Preventive Controls and PCQI compliance management
● Market Position: U.S. food safety regulatory compliance
● Deployment Model: Managed services, subscription support, platform-enabled delivery
● Owner: Consultare Inc. Group