For Regulatory Affairs

Cut Your Literature Review Time by 90%

Nutra Comp is the AI research assistant that helps regulatory professionals find clinical evidence, evaluate claim strength, and produce substantiation documentation — faster than ever.

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90%

Reduction in literature review time

5 min

Average report generation

30+

Regulatory glossary terms defined

As a regulatory affairs professional, you're the gatekeeper between product claims and FDA compliance. You know that thorough substantiation requires exhaustive literature reviews, evidence grading, and meticulous documentation. Nutra Comp doesn't replace your expertise — it amplifies it, automating the time-consuming evidence search so you can focus on judgment calls and strategic guidance.

The Challenges You Face

Drowning in PubMed searches

Manually searching, screening, and extracting data from dozens or hundreds of papers for each claim is the most time-intensive part of your job.

Clients need answers yesterday

Brand teams want claim approvals fast, but thorough evidence review can't be rushed — until now.

Keeping up with evolving enforcement

FDA and FTC enforcement patterns shift. You need to stay current on which claim types are drawing scrutiny and what level of evidence is expected.

Documenting your rationale

Substantiation isn't just about having evidence — it's about creating a defensible record of your analysis. Manual documentation is tedious but essential.

How Nutra Comp Helps

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Targeted Evidence Discovery

AI-powered search returns the most relevant RCTs, systematic reviews, and meta-analyses for any ingredient-claim combination, ranked by study quality.

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Evidence Strength Grading

Every claim comes with a confidence score based on study design, sample size, consistency of results, and statistical significance — the same factors you evaluate manually.

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Exportable Substantiation Memos

Generate professional substantiation memos ready for regulatory files, internal review, or client delivery.

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Scalable Across Portfolios

Run substantiation reports across entire product lines. Manage multiple brands or clients from a single dashboard.

Explore Related Ingredients

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34 studies · Stress & Anxiety

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47 studies · Blood Sugar Support

Vitamin C

168 studies · Immune Function

Melatonin

112 studies · Sleep

Turmeric

91 studies · Inflammatory Response

Key Regulatory Concepts

Structure–Function Claim

A statement describing the role of a nutrient or dietary ingredient in affecting the normal structure or function of the human body. This is the primary type of claim permitted on dietary supplement labels under DSHEA.

Substantiation

The process of gathering and documenting competent and reliable scientific evidence to support the health-related claims made on dietary supplement labels and marketing materials.

New Dietary Ingredient (NDI)

A dietary ingredient that was not marketed in the United States before October 15, 1994. Manufacturers must submit a pre-market safety notification (NDI notification) to the FDA at least 75 days before marketing a supplement containing an NDI.

FDA Warning Letter

An official communication from the FDA to a company or individual that identifies significant regulatory violations and demands corrective action. Warning letters are public records and can trigger marketplace delistings.

FTC Enforcement

The Federal Trade Commission's regulation of advertising claims for dietary supplements. While the FDA regulates labelling, the FTC has jurisdiction over advertising — including websites, social media, email, and paid ads.

Frequently Asked Questions

Does Nutra Comp replace regulatory judgment?

No. Nutra Comp automates evidence discovery and initial claim assessment. Final regulatory decisions should always involve qualified regulatory professionals.

What evidence sources does Nutra Comp use?

Our AI searches indexed clinical trial databases for human studies including RCTs, meta-analyses, systematic reviews, and observational studies.

Can I use Nutra Comp reports in FTC substantiation files?

Nutra Comp reports are designed to support — not replace — your substantiation files. They provide a structured starting point that you can review, refine, and include in your regulatory documentation.

Is Nutra Comp suitable for NDI notifications?

While Nutra Comp can help gather safety and efficacy evidence for NDI submissions, the NDI notification process has specific FDA requirements that require specialised regulatory expertise.

Supercharge Your Regulatory Workflow

Join regulatory professionals who are using AI to deliver faster, more thorough substantiation — without sacrificing rigor.

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