Qaulconform

Transform Your Business with Food Safety services

At Qual Conform, we understand the critical importance of food safety and the evolving regulatory landscape that governs it. Our comprehensive FDA consulting services guide food manufacturers, processors, and distributors through every stage of product development, production, and distribution, ensuring compliance with FDA regulations and industry best practices. From regulatory strategy to implementation of robust food safety systems, Qual Conform is your expert partner in navigating the complex world of food safety regulations.

Regulatory Strategy and Compliance

Qual Conform ensures your operations meet FSMA requirements:

– Comprehensive FSMA gap analysis and compliance strategy

– Preventive controls implementation for human and animal food

– Foreign Supplier Verification Program (FSVP) development

– Produce safety rule compliance support

– Intentional adulteration mitigation strategies

– Sanitary transportation practices implementation

Qual Conform streamlines your FDA registration process:

– Food facility registration and biennial renewal

– Prior notice of imported foods

– Reportable Food Registry submissions

– Facility inspection readiness and support

– FDA Form 483 and Warning Letter response assistance

Food Safety Management Systems

Qual Conform helps implement robust HARPC systems:

– Hazard analysis and risk assessment

– Preventive controls determination and implementation

– Monitoring and verification procedures development

– Corrective action and recall plan creation

– Record-keeping system design and implementation

Qual Conform supports HACCP implementation across various food sectors:

– HACCP plan development and validation

– Critical Control Point (CCP) identification and monitoring procedures

– Verification and documentation system design

– HACCP team training and certification support

– Regulatory compliance assessment for HACCP programs

Qual Conform ensures your facilities meet GMP standards:

– GMP gap assessments and remediation planning

– Standard Operating Procedure (SOP) development

– Sanitation Standard Operating Procedures (SSOPs) creation

– Employee training program development and implementation

– Environmental monitoring program design



Qual Conform helps protect your products and brand:

– Vulnerability assessments for intentional adulteration

– Food defense plan development and implementation

– Food fraud mitigation strategy creation

– Crisis management and communication planning

– Supply chain integrity program development



Food Safety Management Systems

Qual Conform guides you through the FCS notification process:

– FCS regulatory status determination

– Safety assessment and data gap analysis

– Migration studies and exposure assessments

– FCS notification preparation and submission

– FDA communication and response management

Qual Conform supports your GRAS initiatives:

– GRAS eligibility assessment

– Scientific literature review and gap analysis

– Safety assessment and toxicology studies coordination

– GRAS panel selection and management

– GRAS notification preparation and submission to FDA

– Self-affirmed GRAS process support

Qual Conform manages complex food additive petitions:

– Regulatory strategy development for new food additives

– Safety data compilation and evaluation

– Chemistry and manufacturing controls (CMC) documentation

– Environmental assessment preparation

Qual Conform helps protect your products and brand:

– Vulnerability assessments for intentional adulteration

– Food defense plan development and implementation

– Food fraud mitigation strategy creation

– Crisis management and communication planning

– Supply chain integrity program development



Food Safety Management Systems

Qual Conform ensures compliance with infant formula regulations:

– New infant formula notification preparation

– Quality factor requirements assessment

– Current Good Manufacturing Practice (CGMP) compliance for infant formulas

– Labeling review for infant formula products

– FDA registration for infant formula manufacturers

Qual Conform facilitates market entry for innovative food products:

– TMP eligibility assessment for novel food technologies

– Application preparation and submission

– Label development for TMP products

– Market test design and data collection strategy

– Transition planning from TMP to full compliance

Food Safety Management Systems

Qual Conform ensures your product labels meet all regulatory requirements:

– Nutrition Facts panel development and review

– Serving size determination and declarations

– Percent Daily Value calculations

– Nutrient content claim compliance

– Health claim eligibility assessment and substantiation

– Allergen labeling and precautionary statements

Qual Conform provides expert guidance on ingredient labeling:

– Ingredient statement development and review

– Common or usual name determinations

– Standards of identity compliance assessment

– Natural, organic, and non-GMO labeling claims

– Bioengineered (BE) food disclosure compliance

Qual Conform supports chain restaurants and similar retail food establishments:

– Menu labeling strategy development

– Nutrient analysis for standard menu items

– Calorie and nutrition information display guidance

– Written nutrition information preparation

– Compliance assessment for self-service foods and display tags

Qual Conform helps ensure your marketing materials are compliant:

– Structure/function claim development and substantiation

– Health claim and qualified health claim assessment

– “Fresh,” “Natural,” and similar claims evaluation

– Website content review for regulatory compliance

– Social media and digital marketing guidance

Food Testing and Quality Assurance

Qual Conform ensures your product labels meet all regulatory requirements:

– Nutrition Facts panel development and review

– Serving size determination and declarations

– Percent Daily Value calculations

– Nutrient content claim compliance

– Health claim eligibility assessment and substantiation

– Allergen labeling and precautionary statements

Qual Conform provides expert guidance on ingredient labeling:

– Ingredient statement development and review

– Common or usual name determinations

– Standards of identity compliance assessment

– Natural, organic, and non-GMO labeling claims

– Bioengineered (BE) food disclosure compliance

Qual Conform supports chain restaurants and similar retail food establishments:

– Menu labeling strategy development

– Nutrient analysis for standard menu items

– Calorie and nutrition information display guidance

– Written nutrition information preparation

– Compliance assessment for self-service foods and display tags

Qual Conform helps ensure your marketing materials are compliant:

– Structure/function claim development and substantiation

– Health claim and qualified health claim assessment

– “Fresh,” “Natural,” and similar claims evaluation

– Website content review for regulatory compliance

– Social media and digital marketing guidance

Food Testing and Quality Assurance

Qual Conform designs comprehensive testing strategies:

– Microbiological testing program development

– Chemical contaminant testing strategies

– Allergen control and testing programs

– Shelf-life studies and challenge testing

– Laboratory audit and compliance support

Qual Conform strengthens your supply chain integrity:

– Supplier approval and verification programs

– Risk-based supplier audits

– Certificate of Analysis (COA) review and management

– Import and export compliance support

– Traceability system development and implementation

Learn more about Food Testing and Quality Assurance

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