Generate FDA-compliant labels from Certificate of Analysis (COA) data. Built for contract labs serving supplement and food brands — auto-format, audit trail, white-label export.
Real-world compliance and workflow issues contract labs hit most often — and how ReguSift prevents each one before export.
Lab tech manually transcribes COA into label template
AI ingests COA and auto-generates FDA-compliant label
Contract labs produce COAs with detailed analytical data, but brand clients need consumer-facing labels. Manual transcription is slow and creates naming drift.
ReguSift fix: ReguSift AI ingests COA data (PDF, image, Excel) and auto-generates FDA-compliant labels. No manual transcription, no naming drift.
Ref: 21 CFR 101.36 — Supplement Facts formatting
Contract labs serve multiple brand clients. ReguSift ingests COA data, auto-generates FDA-compliant labels, and supports white-label export — every conversion has an ISO 17025-ready audit trail.
For contract manufacturers, audit trails aren't optional — they're NDA evidence. ReguSift logs every extraction, rounding, sorting, and export decision with timestamps and regulatory citations, so you can prove compliance during client audits.
Magnesium (as Magnesium Glycinate) — raw: 200.4 mg
Magnesium (as Magnesium Glycinate) — 200 mg
Ref: 21 CFR 101.36(b)(2)(iii): rounds to nearest 1 mg for nutrients > 14 mg/serving
Magnesium 200 mg · RDI 420 mg
Magnesium 200 mg · 48% DV
Ref: FDA RDI table (adults): 420 mg/day for Magnesium; 200/420 = 47.6% → rounds to 48%
Blend: Valerian 50mg, Magnesium 200mg, L-Theanine 80mg
Blend: Magnesium 200mg, L-Theanine 80mg, Valerian 50mg
Ref: 21 CFR 101.36(b)(3)(ii): blend ingredients listed by descending weight
Draft status — pending QA review
Approved → PNG 2x exported · audit trail locked
Ref: Workspace isolation verified: Client A formula invisible to Client B workspace
The exact specs contract labs need. ReguSift exports meet all of them by default.
Multi-format COA ingestion with AI + OCR
Client branding added to FDA-compliant label
Every decision timestamped for FDA inspection
Isolated formulas with role-based access
Manual COA → label transcription is slow and error-prone. ReguSift automates the entire workflow with audit trail.
| Dimension | Manual Transcription | ReguSift for Contract Labs |
|---|---|---|
| COA-to-label time | 30-60 minutes per COA | Under 60 seconds per COA |
| Naming consistency | Manual translation, error-prone | Auto-translated to FDA consumer naming |
| White-label | Manual branding per client | Pro tier white-label export |
| Audit trail | Manual records, incomplete | ISO 17025-ready, automatic |
Data privacy belongs in the product, not in fine print — especially for contract labs.
Each brand client's COAs and formulas are isolated. Role-based access controls prevent cross-client data leakage.
Your clients' COAs and proprietary analytical data are never used to train foundational models.
Every COA extraction, rounding decision, and export is timestamped. Suitable for FDA inspection when defending analytical decisions.
Contract labs serve as the analytical backbone for supplement and food brands. This guide covers the 3 compliance layers contract labs must navigate when delivering COA → label conversions.
Labs use analytical naming; FDA labels use consumer naming. The translation is non-trivial:
Contract labs often need to deliver FDA-compliant labels with their client's branding:
When FDA audits a brand client, the contract lab must produce evidence of every analytical decision. ReguSift provides:
Everything contract labs need to know before getting started.
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Try the live sandbox with a sample COA — no sign-up required. Upload your own when you're ready.
Stop rebuilding supplement panels by hand. Simply drag your raw files right into the box to let our layout engine do the heavy lifting instantly.
Drop your raw files right into the box. We will build your structured template immediately.
Click to browse or drop file here
PDF, DOCX, XLSX, PNG or JPG up to 25MB
Disclaimer: ReguSift is a software tool that assists with FDA 21 CFR 101.36 and 21 CFR 101.9 label formatting. It is not a substitute for legal or regulatory advice. Free tier exports include a "FREE PREVIEW" watermark.