Regulatory and Quality Compliance
Expert support for FDA FSMA programs, GFSI and ISO standards, HACCP, allergen and food defense programs, USDA Organic, and import/export compliance — ensuring continuous regulatory readiness across your entire operation.
FDA FSMA, Preventive Controls, FSMA 204 & USDA Food Safety Compliance
We help organizations build and maintain fully compliant food safety systems aligned with FDA FSMA regulations, FSMA 204 traceability requirements, and USDA food safety standards, ensuring end-to-end regulatory readiness across your operations.
Our FSMA, FSMA 204 & USDA support includes:
● Preventive Controls (PCQI) program development for human and animal food
● Food Safety Plan creation, hazard analysis, and risk-based preventive controls (HARPC)
●FSMA 204 Traceability Rule compliance, including KDE (Key Data Elements), CTE (Critical Tracking Events), digital traceability record design, and workflow implementation
● USDA food safety compliance for meat, poultry, egg products, and regulated facilities
● Foreign Supplier Verification Program (FSVP) compliance for importers
● Recall preparedness, traceability systems, and crisis management planning
● Environmental monitoring, verification procedures, and corrective action workflows
● Supplier approval, qualification, and ongoing monitoring programs
We ensure your food safety systems are structured, validated, fully traceable, aligned with federal regulations, and inspection-ready for FDA, USDA, and third-party auditors.
Food Safety Plan, HACCP, Allergen & Food Defense Programs
We design, develop, review, and enhance comprehensive product safety systems that meet FDA, USDA, GFSI, and industry expectations.
Our specialized programs include:
● Food Safety Plan (FSP) development under FDA Preventive Controls (HARPC / PCQI)
● HACCP plan development, validation, and ongoing maintenance
● Allergen control programs and cross-contact prevention strategies
● Food defense and vulnerability assessments (VA) aligned with FDA requirements
● Prerequisite programs (PRPs) and Sanitation Standard Operating Procedures (SSOPs)
● Corrective action workflows, root-cause analysis, and monitoring plans
● Process validations, verifications, and environmental monitoring procedures
Our approach ensures robust hazard management, regulatory compliance, and consistent program execution across production, processing, and distribution environments.
GFSI Standards & Third-Party Certification Support
We help organizations meet the documentation, process, and audit requirements necessary to comply with major GFSI schemes and third-party certification programs across the global food supply chain.
We support the following GFSI-recognized schemes:
● SQF (Safe Quality Food)
● FSSC 22000 (Food Safety System Certification)
● BRCGS (Brand Reputation Compliance Global Standards)
● IFS (International Featured Standards)
● GLOBALG.A.P. (Good Agricultural Practices)
● PrimusGFS (Produce safety and agricultural supply-chain certification)
● CanadaGAP (Produce and greenhouse Good Agricultural Practices)
● GAA BAP (Best Aquaculture Practices)
Our certification support includes:
● System development, implementation, and maintenance
● Internal audit and gap assessment programs
● CAPA management and continuous improvement processes
● Auditor interview preparation and readiness coaching
● Digital documentation, workflow automation, and recordkeeping systems
We help ensure your organization achieves certification, maintains ongoing compliance, and stays fully prepared for scheduled or unannounced audits.
ISO Quality, Safety & Compliance Management Systems
We develop, implement, and support ISO-aligned programs that strengthen quality, safety, security, and operational consistency across your organization.
ISO standards we support include:
● ISO 9001 – Quality Management Systems
● ISO 22000 – Food Safety Management Systems
● ISO 27001 – Information Security Management Systems
● ISO 45001 – Occupational Health & Safety Management Systems
● ISO 14001 – Environmental Management Systems
● ISO 31000 – Risk Management Guidelines
● ISO 13485 – Medical Devices Quality Management
● ISO 17025 – Testing & Calibration Laboratories
● ISO 22301 – Business Continuity Management
● ISO 20000-1 – IT Service Management
● ISO 50001 – Energy Management Systems
● ISO 14971 – Risk Management for Medical Devices
● ISO/IEC 27701 – Privacy Information Management Systems
Our ISO services include:
● Documentation development and implementation
● Policies, procedures, manuals, and record systems
● Internal audits and gap assessments
● Corrective action and continuous improvement programs
● Employee training and competency development
● Performance monitoring and audit readiness
We build structured, auditable workflows that align with ISO requirements and support successful certification and long-term system maintenance.
FDA, USDA, OSHA, FTC & Import/Export Compliance
We support organizations in navigating complex federal, state, and international regulatory requirements to ensure full compliance from manufacturing through market entry.
Our regulatory services include:
● FDA compliance programs, including FSMA, FSVP, PCQI, facility registration, Prior Notice, corrective actions, and documentation management
● USDA Organic program development, certification support, and ongoing compliance oversight
● OSHA compliance, including workplace safety programs, hazard controls, documentation, training, and regulatory readiness
● FTC compliance, including labeling and marketing claims review for food, supplements, cosmetics, and consumer goods
● Import and export regulatory verification for food products, ingredients, manufactured goods, and consumer items
● Supplier documentation and country-of-origin compliance, including foreign supplier qualification and verification
● Labeling and claims review, covering organic, non-GMO, allergen, nutrition facts, ingredient statements, health claims, and marketing representations
● Shipment documentation and oversight, including IOR coordination, customs requirements, and FDA Prior Notice submissions
We help ensure your products meet all FDA, USDA, OSHA, FTC, and international compliance expectations, supported by structured, audit-ready systems that protect your brand and streamline regulatory operations.
Ensure continuous regulatory readiness with expert guidance and structured compliance programs.
Let us support your food safety, quality, and export/import compliance needs.