FDA Compliance & Safety Solutions
FOOD & BEVERAGE
FROM CONCEPT TO CONCLUSION
Burdock Group delivers tailored strategies and expert guidance to help businesses navigate complex FDA regulations.
With years of experience, we ensure products meet the highest safety standards while supporting regulatory compliance and market success.
GRAS Determinations for Food Ingredients
In the U.S., a substance must be an approved food additive or Generally Recognized as Safe (GRAS) before it can be added to food. Most companies pursue GRAS through GRAS Notification or Independent GRAS (self-GRAS).
At Burdock Group, our expertise, accessibility, and practical approach give you confidence that your products meet safety and regulatory standards and allow you to pass that confidence on to your customers.
With extensive experience in FDA compliance and toxicology, we guide clients efficiently through the GRAS process, helping ensure timely and successful regulatory approval.
GENERALLY RECOGNIZED AS SAFE (GRAS)
SAFETY ASSESSMENTS & OPINION LETTERS
STUDY PROTOCOL DEVELOPMENT & STUDY MONITORING
CLAIMS CONSULTING & SUBSTANTIATION
LITIGATION & DEFENSE RESEARCH
FEASIBILITY & GAP ASSESSMENTS
FOOD CONTACT NOTIFICATIONS
LABEL REVIEWS
GOVERNMENT AGENCY REPRESENTATION
EXPERT WITNESSING
REGULATORY ASSESSMENTS
FOOD & COLOR ADDITIVE PETITIONS (FAP)
STABILITY DATA & SPECIFICATION DEVELOPMENT
FOOD RECALLS & RISK ASSESSMENTS
GENERAL CONSULTING SERVICES
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