GRAS notice to FDA

Unlock US Market Access with Expert GRAS Notice Guidance.

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Achieving Generally Recognized as Safe (GRAS) status for your food ingredients is a pivotal milestone for gaining market access in the United States. At Biosafe, we specialize in steering your GRAS notice through the FDA’s intricate submission process. Our comprehensive consulting services simplify the complex journey of attaining GRAS recognition, ensuring your food products meet the food safety regulations and rigorous safety standards set by the U.S. Food and Drug Administration (FDA).

Why Biosafe

Personalized Approach: We understand that each GRAS notice is unique. Our personalized approach ensures that your submission strategy is tailored to the specific requirements of your ingredient.
Expertise Across Phases: From initial evaluation to final submission, Biosafe offers a full spectrum of services tailored to each phase of the GRAS notification process.
Strategic Compilation: We adeptly compile the requisite scientific data, expert opinions, and comprehensive documentation essential for a successful GRAS submission.
Regulatory Insight: Our in-depth understanding of FDA requirements and guidelines ensures your GRAS notice adheres to the highest standards, facilitating a smoother review process.

Pre-Submission Assessment: We begin with a thorough evaluation of your ingredient, reviewing existing data and identifying any gaps that need addressing before submission.
Scientific Data Compilation: Our team compiles and organizes all necessary scientific evidence, including safety studies, historical consumption data, and expert consensus, to support the safety of your ingredient.
Expert Panel Consultation: We facilitate consultations with an expert panel to review the safety evidence and provide a critical opinion, an essential component of the GRAS dossier.
Documentation and Dossier Preparation: Our experts meticulously prepare the GRAS notice dossier, ensuring it meets the FDA’s stringent requirements for format, content, and scientific rigor.
Submission and Follow-Up: Upon completing the dossier, we manage the submission process to the FDA and provide continuous support, addressing any queries or additional information requests from the agency.
Regulatory Support Post-Submission: Even after submission, our commitment to your success continues. We offer ongoing regulatory support to navigate post-submission inquiries and maintain compliance with FDA regulations.