At InterlinkIQ, we provide comprehensive services to ensure your medical food products comply with the Center for Food Safety and Applied Nutrition (CFSAN) regulations. Our expertise covers every aspect of medical food program compliance, from product development to ongoing quality management.
Here’s how we can support your compliance needs:
Regulatory Consultation
Receive expert guidance on FDA regulations tailored specifically to medical foods. Our team provides clear interpretations of CFSAN guidelines to help you navigate complex regulatory landscapes.
Medical Food Product Development
We assist with the formulation and ingredient selection of medical foods to meet regulatory criteria. Our services include comprehensive documentation support for medical food claims and labeling requirements.
Labeling and Claims Review
Ensure your product labels meet FDA standards with our thorough review and development services. We verify health claims, nutritional information, and all required labeling elements to ensure compliance.
Quality Management Systems (QMS) Implementation
Implement a robust Quality Management System designed for medical food production. We guide you through adhering to Good Manufacturing Practices (GMPs) and maintaining high-quality standards.
Food Safety Plan Development
Develop a Food Safety Plan that includes hazard analysis and risk-based preventive controls. We assist in implementing and monitoring safety procedures to ensure your products are safe and compliant.
HACCP Plan Development
Design and implement a Hazard Analysis and Critical Control Points (HACCP) plan specific to medical foods. We ensure your HACCP plans are up-to-date and effective in managing food safety risks.
Compliance Audits and Inspections
Prepare for FDA inspections with our internal audits and compliance assessments. We help you stay audit-ready and ensure you meet all regulatory requirements.
Documentation and Record Keeping
We support the development and maintenance of documentation and records necessary for medical
food compliance. Our services ensure that your records are complete and ready for audits.
Training and Education
Equip your team with the knowledge they need through our training programs. We offer education on FDA guidelines, quality management practices, and food safety to keep your staff informed and compliant.
Risk Management and Mitigation
Identify and assess risks associated with medical food production. Our risk management strategies help you develop controls to mitigate potential issues and ensure product safety.
Regulatory Submissions
Receive assistance with preparing and submitting necessary documentation and reports to the FDA. We support you through premarket notifications and other regulatory filings to streamline the submission
process.
Product Recall Management
Develop effective recall procedures and strategies with our support. We help manage product recalls to ensure compliance with regulatory requirements and protect your brand.
Labeling Compliance
Ensure your product labels meet all FDA requirements for medical foods. We review labels to confirm they include all necessary information, from ingredient lists to nutritional details.
At InterlinkIQ, we are dedicated to helping you achieve and maintain compliance with CFSAN regulations, ensuring your medical foods are safe, effective, and of the highest quality. Contact us today to learn more about how our services can benefit your business.
