MoCRA Ops Kit
Coming Soon — Join the Waitlist

MoCRA recordkeeping for Shopify cosmetic brands — without spreadsheets.

Centralize safety substantiation per SKU. Never miss the 15 business-day serious adverse event clock. Export consistent documentation packs on demand.

  • Built around the 15 business-day serious adverse event clock
  • Exports include an audit manifest (versions + timestamps)
  • No filings, no legal advice — just clean recordkeeping

Built for

US-selling Shopify cosmetics, skincare, and haircare brands

Not for

Enterprise QMS, filing services, or public complaint intake

Join the Waitlist
Beta pricing starts at $29/mo • Most brands choose ~$79/mo

Get Early Access

Be the first to know when we launch.

See It In Action

Clean interfaces. Organized records. Clear exports.

Product Safety Vault interface showing SKU-linked documents

Product Safety Vault

SKU-linked documents with version history

Adverse Event Case tracking with 15 business-day countdown

Adverse Event Case

15 business-day clock with due-by date tracking

Audit Pack Export with ZIP structure and manifest

Audit Pack Exports

Manifest + deterministic ZIP structure

Core Features

Everything you need for MoCRA readiness

Purpose-built tools to help Shopify cosmetic brands organize the documentation they need for FDA's Modernization of Cosmetics Regulation Act.

Product Safety Vault

Organize labels, safety substantiation docs, and supplier documentation per SKU. Structured, versioned records — exportable with an audit manifest (versions + timestamps).

Adverse Event Log

Internal-only workflow for product-related issues. Track the 15 business-day serious adverse event reporting clock. Clear due-by dates, no calendar-day ambiguity.

One-click Audit Pack Export

Generate deterministic ZIP packages on demand. Every export includes a manifest (CSV/HTML index) with versions and timestamps (checksums planned) for full traceability.

MoCRA Profile Tracker

Track facility registration status (renewed every 2 years) and product listing updates (annual, including discontinuations) — plus upload proof docs and get deadline reminders. We do not file anything on your behalf.

SAE Submission Package Export

Generate a Form 3500A-ready packet with label + attachments for serious adverse event reporting — including a checklist for follow-up info received within 1 year (also due within 15 business days). You submit through official FDA channels — we just prepare the package.

Privacy-First

No tracking cookies. We hash IPs for abuse prevention only. Your data stays yours.

Shopify-Native

Built from the ground up for Shopify cosmetic brands. No generic SaaS complexity.

Deterministic Exports

Consistent exports every time. Audit manifest includes versions, timestamps, and file checksums.

FAQ

Frequently Asked Questions

Important information about what MoCRA Ops Kit does — and doesn't do.

No. MoCRA Ops Kit is a recordkeeping tool only.

Registration & Listing: You submit via FDA Cosmetics Direct. We just track your status.

Serious Adverse Events: You submit via FDA MedWatch (Form 3500A). We generate the package for you to submit.
No. MoCRA Ops Kit is not a law firm and does not provide legal advice. Using our tool does not guarantee compliance with MoCRA or any other regulations. We provide organizational tools to help you maintain records—always consult with a qualified regulatory attorney or consultant for compliance guidance.
No. FDA registration and product listing are not FDA approval — they are notifications. MoCRA Ops Kit does not certify or approve anything. We do not provide any verification or endorsement. This is recordkeeping tooling that helps you organize and export your own documentation.
We collect only what's necessary to operate the service: your email address, optional store URL, product category, and SKU count for the waitlist. We do not store raw IP addresses (only a hashed version for abuse prevention). We use Cloudflare Turnstile for bot protection, which does not use cookies or track users. See our Privacy Policy for full details.
MoCRA Ops Kit is built specifically for Shopify cosmetic, skincare, and haircare brands selling in the United States with approximately 5–200 SKUs and small teams. If you manufacture or distribute cosmetic products that fall under FDA's MoCRA regulations, our tool helps you organize the safety files, internal logs, and documentation you may need.
We're building:
  • Product Safety Vault — Organize labels, safety substantiation docs per SKU
  • Adverse Event Log — Track the 15 business-day serious adverse event clock
  • Audit Pack Exports — Deterministic ZIPs with manifest (versions + timestamps)
  • MoCRA Profile Tracker — Track registration/listing status (no filing)
  • SAE Submission Package Export — Generate 3500A-ready packets (no submission)
  • Batch Transparency Page (Growth+ plan) — Public pages with disclaimer: "Provided by the brand. Not independently verified."

Ready to simplify your MoCRA recordkeeping?

Join the waitlist today and be among the first Shopify cosmetic brands to experience streamlined compliance documentation.

Join the Waitlist