At InterlinkIQ, we specialize in providing comprehensive Medical Food Program Management services to ensure your products comply with the stringent standards set by the Center for Food Safety and Applied Nutrition (CFSAN) and the Food and Agriculture Compliance and Technical Support (FACTS) guidelines. Our expert team is dedicated to helping you manage and optimize your medical food programs with the following services:
Regulatory Compliance
CFSAN Adherence
We guide you through compliance with CFSAN regulations.
FACTS Guidelines
Integration of FACTS guidelines to meet all necessary requirements.
Program Development
Comprehensive Program Creation
We develop tailored medical food programs to suit your specific needs.
SOP Development
Establishment of standard operating procedures (SOPs) for consistent and compliant operations.
Quality Management
Quality Management Systems (QMS)
Development and implementation of QMS to ensure product quality.
Quality Control and Assurance
Establishment of processes to maintain high standards and consistent quality.
Food Safety Plans
Custom Food Safety Plans
Creation of Food Safety Plans specific to medical foods.
Risk Assessment
Identification and management of risks to ensure product safety.
HACCP Implementation
HACCP Plans
Development and implementation of Hazard Analysis and Critical Control Points
(HACCP) plans.
System Monitoring
Regular updates and monitoring to ensure HACCP systems remain effective.
Preventive Controls
Preventive Measures
Integration of preventive controls into your production processes.
Control Strategies
Development of strategies to manage potential hazards.
Compliance Audits
Internal and External Audits
Conducting audits to assess and ensure compliance.
FDA Inspections
Preparation and support for FDA inspections and regulatory reviews.
Training and Education
Staff Training
Comprehensive training programs on regulatory requirements and best practices.
Ongoing Education
Continuous education on CFSAN and FACTS guidelines.
Documentation and Record Keeping
Program Documentation
Development and management of all necessary documentation.
Record Keeping
Maintaining accurate and complete records for compliance.
Risk Management
Risk Identification
Assessment and management of risks associated with medical food
production.
Risk Strategies
Development of risk management plans and strategies.
Regulatory Submissions
Document Preparation
Assistance with preparing and submitting regulatory documents and
reports.
Premarket Notifications
Support for premarket notifications and other regulatory filings.
Product Lifecycle Management
Lifecycle Management
Oversight of medical food products throughout their lifecycle.
Performance Monitoring
Ongoing monitoring of product performance and compliance.
Labeling Compliance
Label Review
Verification of labeling to ensure compliance with CFSAN and FACTS standards.
Label Validation
Review and validation of product labels for accuracy.
Program Evaluation and Improvement
Program Evaluation
Regular assessment of program effectiveness.
Continuous Improvement
Recommendations for optimization and improvement.
Consultation and Support
Expert Consultation
Professional advice on managing medical food programs.
Ongoing Support
Continued support for regulatory and industry compliance.
At InterlinkIQ, we are committed to ensuring your medical food programs are compliant, efficient, and optimized for success. Contact us today to learn more about how our services can support your program management needs.
