FDA Compliance Software to Ace Your Audits

Reglyr automates ingredient screening, label reviews, and claim validation against FDA rules — giving your team instant GO/FIX verdicts before audits catch you off guard.

Why FDA Compliance Goes Wrong

Manual compliance processes create gaps that surface at the worst possible moment — audits, launches, and retailer reviews.

Audit Gaps From Manual Checks

Spreadsheet-driven reviews miss ingredient restrictions and label errors that FDA auditors find immediately, putting your product approval at risk.

Claims That Create Liability

A health or structure/function claim that lacks FDA substantiation can trigger warning letters and force a costly product reformulation after launch.

No Visibility Until It Is Too Late

Without continuous monitoring, a regulatory update to permissible additives or labeling formats can make a compliant SKU non-compliant overnight.

Built for Every Layer of FDA Compliance

From ingredient screening and claim validation to label scanning and ongoing regulatory monitoring — Reglyr covers every FDA compliance checkpoint your team faces.

Screen Every Ingredient Against FDA Rules

FDA Ingredient Review

Screen Every Ingredient Against FDA Rules

Check each ingredient against GRAS status, permitted additives lists, and market-specific restrictions simultaneously. Surface disqualifying substances before they reach your label or your auditor.

  • GRAS and permitted additives screening
  • Market-specific restriction checks
  • Instant GO/FIX/REVIEW per ingredient
Validate Health Claims Before You Launch

FDA Claim Compliance

Validate Health Claims Before You Launch

Automatically checks health and structure/function claims against FDA rules and substantiation requirements. Flag non-compliant claims at the draft stage — not after a warning letter arrives.

  • FDA structure/function rule checks
  • EU Health Claims Register cross-check
  • Claim-level compliance verdicts
Scan Labels for FDA Format Errors

Label Compliance

Scan Labels for FDA Format Errors

AI reviews nutrition panel formatting, allergen declaration completeness, mandatory label elements, and barcode compliance against FDA requirements — catching errors before printing or submission.

  • Nutrition panel format validation
  • Allergen declaration completeness
  • Mandatory element gap detection
Track FDA Regulatory Changes Automatically

Regulatory Intelligence

Track FDA Regulatory Changes Automatically

Stay ahead of updates to FDA ingredient lists, labeling rules, and claim guidance. Reglyr flags affected SKUs automatically so your team acts before a compliance gap becomes an audit finding.

  • Automatic FDA update tracking
  • Affected SKU flagging
  • Propagated documentation changes
Full Compliance Record for FDA Audits

Audit Readiness

Full Compliance Record for FDA Audits

Every ingredient check, claim validation, and label scan is logged with full traceability from source document to compliance record — giving auditors and inspectors a clean, verifiable paper trail.

  • Source-to-record traceability
  • Inspection-ready documentation
  • Complete compliance history per SKU

Frequently Asked Questions

See FDA Compliance Without the Manual Work

Book a demo to see how Reglyr screens ingredients, validates claims, and flags label errors against FDA requirements.

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