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Your Trusted Partner in PCQI Compliance

Professionally Managed by Consultare Inc. Group, a Regulatory Compliance Company

At PCQIServices.com, we specialize exclusively in Preventive Controls Qualified Individual (PCQI) services to help food and dietary supplement companies meet U.S. Food and Drug Administration (FDA) requirements under the Food Safety Modernization Act (FSMA). Our goal is to ensure your facility is audit-ready, compliant, and led by qualified professionals who understand risk-based preventive controls.

About Us

PCQIServices.com is professionally managed by Consultare Inc. Group, a regulatory compliance firm with extensive experience in food safety systems, U.S. import regulations, and FDA requirements. We provide targeted solutions for companies seeking to implement, maintain, or outsource their PCQI responsibilities.

Our Core Service: PCQI Compliance Management

We support companies in establishing and maintaining a compliant food safety plan by offering:

✅ Designated PCQI Representation

Appoint a qualified individual to serve as your official PCQI, overseeing your food safety system in accordance with 21 CFR Part 117 Subpart C.

✅ Food Safety Plan Development & Oversight

We help develop, implement, and maintain food safety plans tailored to your product category, process flow, and facility structure, including:
  • Hazard Analysis
  • Preventive Controls (Process, Allergen, Sanitation, Supply Chain)
  • Monitoring Procedures
  • Corrective Actions
  • Verification and Validation Activities
  • Recordkeeping Requirements

✅ PCQI-Led Audits & Documentation Review

Our PCQI professionals conduct internal audits and documentation assessments to ensure your systems are compliant with FDA and third-party certification bodies.

✅ Remote and Onsite Support

Whether you need a full-time outsourced PCQI or periodic consulting, our services are available both remotely and on-location, depending on your operational needs.

Why Choose PCQIServices.com?

🔹 FDA-Focused Expertise

We work exclusively within the FSMA framework and stay up to date with evolving FDA enforcement trends.

🔹 Customized, Risk-Based Solutions

No two facilities are the same. Our PCQI services are tailored to your risk profile, supply chain, and regulatory exposure.

🔹 Immediate Readiness for FDA Inspections

We prepare your food safety plan and documentation to be audit-ready at all times, minimizing risk and disruption during inspections.

🔹 Support for U.S. and Foreign Facilities

Whether you’re a U.S.-based manufacturer or a foreign exporter registered with the FDA, we ensure your PCQI compliance aligns with regulatory expectations.

OUR MISSION

To provide reliable, expert-led PCQI services that support food safety, regulatory compliance, and confidence across the global supply chain.

OUR VISION

To be the trusted PCQI compliance partner for food and supplement companies committed to safety, transparency, and regulatory integrity.

Let's Get Started

Whether you need a PCQI to lead your food safety program, conduct a hazard analysis, or prepare for an inspection, PCQIServices.com is ready to support you.

📞 Contact us today to schedule your initial consultation.

Let us handle PCQI compliance—so you can focus on what you do best: delivering safe, quality products to your customers.