NoQuestionsAI guides you step-by-step through creating a complete GRAS notification — structured to 21 CFR Part 170, backed by real regulatory data, and ready for FDA submission.
A structured conversation replaces the blank-document guesswork. Answer questions, and watch your dossier take shape in real time.
Tell the AI what substance you're seeking GRAS status for. It begins the guided interview immediately, starting with identity and composition.
The AI walks you through all 7 required sections of a GRAS notification — one or two questions at a time, adapting based on your answers and citing real precedent.
Your dossier builds as you chat. Open the full-screen document view at any time to see your formatted submission taking shape. Edit any section with a built-in rich text editor.
Save as PDF with a cover page, table of contents, all 7 regulatory parts, and bibliography — ready for your regulatory team and submission to OFAS/CFSAN.
Purpose-built tools for regulatory professionals — not another generic document editor.
Conversational AI trained on FDA GRAS requirements, regulatory language, and submission best practices. Asks structured questions and guides you through every section.
Your dossier builds as you talk. Every answer is extracted into structured data and rendered into a formal FDA submission document in real time.
Documents follow the exact 7-part structure required by 21 CFR Part 170, Subpart E, from Signed Statements through Supporting Data and Bibliography.
Searches a curated database of GRAS notices, CFR references, FDA guidance documents, and scientific literature to surface relevant precedent.
Visual progress across all 7 dossier sections. Always know where you stand, what's complete, and what still needs attention.
Work on multiple GRAS dossiers simultaneously. Each dossier has its own conversation history, source references, and document.
Designed for the people who actually prepare and review GRAS submissions.
Accelerate dossier preparation with structured AI guidance and automatic document assembly. Spend less time on formatting, more on substance.
Preparing a GRAS notification for a new ingredient? NoQuestionsAI walks you through every requirement, even if you've never filed before.
Translate your technical knowledge into regulatory language. The AI helps you frame safety data, exposure estimates, and processes in FDA-ready format.
Serve more clients, faster. Use NoQuestionsAI as your starting point for dossier preparation, then refine with your expertise.
Choose the plan that fits your workflow. Start with a free trial, upgrade when you're ready.
For individuals preparing a single dossier.
For teams managing multiple submissions.
For organizations with advanced needs.
A GRAS (Generally Recognized as Safe) notification is a voluntary submission to the FDA where a company provides evidence that a food substance is safe under its intended conditions of use. If the FDA has "no questions" about the submission, the substance can be marketed as GRAS.
No. NoQuestionsAI helps you prepare a high-quality dossier, but the FDA's determination depends on the substance, the quality of your safety data, and many other factors. We recommend having a qualified regulatory affairs professional review your dossier before submission.
All 7 parts required by 21 CFR Part 170, Subpart E: Signed Statements and Certification, Identity/Manufacturing/Specifications, Dietary Exposure, Self-Limiting Levels of Use, Common Use History, Safety Narrative, and Supporting Data and Bibliography.
Yes. Every section of the dossier includes a full rich text editor. You can modify, add, or remove content at any point before exporting.
PDF via browser print. The document is formatted as a formal FDA submission with cover page, table of contents, and all 7 regulatory parts — ready for your team to review.
Your dossier data is stored securely and is only accessible to your authenticated account. We use industry-standard encryption and authentication protocols.
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