Facility registration
Each manufacturing or processing facility is registered with FDA, with biennial renewal verified. Registration includes all required fields and U.S. Agent designation for foreign facilities.
The most rigorous MoCRA compliance pack an indie brand can get.
MoCRA Cosmetic Compliance & Safety Substantiation Engine assembles a documentation-complete MoCRA position — facilities registered, every SKU listed, each product safety-substantiated with a qualified-expert-signed safety report, an adverse-event intake running under the 15-business-day clock, and a six-year audit-ready record set — checked against the letter of the Modernization of Cosmetics Regulation Act of 2022 before a specialist releases it.
Every MoCRA obligation under 21 U.S.C. §364Facility registration & product listingSafety substantiation with qualified expert sign-offAdverse-event monitoring & reportingBiennial renewal & annual update SLA
Why compliance fails
A single missing element can trigger an FDA enforcement action.
MoCRA is the first major expansion of FDA authority over cosmetics in over 80 years. As of July 1, 2024, every Responsible Person — the brand owner, distributor, or importer whose name is on the label — must register facilities, list products, maintain safety substantiation, and report serious adverse events within 15 business days. Non-compliance exposes a product to adulterated/misbranding findings, import detention, mandatory recall, and facility-registration suspension.
Most indie brands run this by hand, from memory, once or twice a year. The statute has not been read end-to-end since the last time it mattered. That is exactly where compliance gaps hide.
MoCRA Cosmetic Compliance & Safety Substantiation Engine exists to close that gap with a single, exhaustive standard applied identically to every file.
1 of 4
core MoCRA obligations is enough to jeopardize compliance
The benchmark
Measured against the letter of the statute — section by section.
We do not summarize the law and hope. Every pack is scored against a versioned rule pack tied to the exact text of the Modernization of Cosmetics Regulation Act of 2022. These are the provisions each pack is held to.
Product listing
Every cosmetic product and its ingredients are listed with FDA, including the product's formulation, labeling, and any allergens. Listings are updated annually.
Safety substantiation
Adequate safety substantiation is provided for each product, supported by toxicological data or a written assessment by a qualified expert. The safety report includes ingredient hazard identification, exposure assessment, and margin-of-safety calculation.
Adverse-event reporting
A system for receiving and tracking adverse events is established, with serious adverse events reported to FDA within 15 business days. Records are maintained for six years.
Recordkeeping
All records related to safety substantiation, adverse events, and compliance are maintained for at least six years and are audit-ready.
Good manufacturing practice
Facilities comply with FDA's GMP requirements, with documentation of processes and controls. (GMP audit is referred to partner labs if needed.)
How a pack is built
Intake to specialist release, with deterministic gates the AI cannot overrule.
AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A qualified safety assessor (toxicologist/cosmetic scientist) owns the safety conclusion and signs every release. That order is never reversed.
01
MoCRA Readiness & Gap Scan
Upload your label and ingredient list. We return a free compliance gap report: which MoCRA obligations you already meet, and which are missing, with a fixed quote before you pay.
02
Evidence & data collection
As your authorized agent, we collect product labels, INCI ingredient decks, manufacturing facility details, and any existing safety data. We also order any required third-party tests (e.g., stability, microbiology) through partner labs.
03
Grounded drafting
The AI engine parses labels and ingredient decks, assembles ingredient toxicology from authoritative databases (CIR, SCCS, FDA), computes exposure and margin-of-safety, and drafts the safety report and FDA listing forms — no legal opinions, no invented facts.
04
Deterministic completeness gates
All required fields in FDA forms are verified; ingredient hazard data is cross-referenced; exposure calculations are checked; adverse-event intake procedures are documented. Any failure blocks release.
05
Qualified expert review & sign-off
A qualified safety assessor (toxicologist or cosmetic scientist) reviews the safety report, owns the safety conclusion, and signs it. High-risk or novel ingredients route to additional expert review.
06
Delivery & ongoing maintenance
You receive the complete MoCRA position: facility registration confirmation, product listing receipts, signed safety dossiers, adverse-event intake procedures, and a six-year record set. Annual updates and biennial renewals are managed through a maintenance plan.
The bar we hold
Rigor you can measure.
100%
Qualified-expert-signed
No safety report ships without a qualified assessor's signature.
15 days
Standard SLA
From complete intake to released pack for standard products.
<1%
Critical-defect target
Tracked against a gold-standard compliance pack library.
4
Toxicology database sources
CIR · SCCS · FDA · ECHA, every applicable ingredient.
Why MoCRA Engine
Built to be the most thorough option an indie brand has.
Documentation-complete, by design
The deliverable is completeness itself — every MoCRA obligation accounted for or explicitly exception-coded. Nothing is left implicit.
Deterministic, not vibes
The gates that decide completeness are code, not a model's opinion. A drafting error cannot slip past a statutory requirement.
In its lane, on purpose
We prepare documentation and run searches as your authorized agent. We never give legal advice, and we never represent you before FDA without your direction.
Engagement
Flat fee, per product safety dossier, per facility registration, and per annual maintenance plan. No hourly billing, ever.
Simple, predictable, and aligned with a compliance standard — not a percentage of revenue.
- A free MoCRA Readiness & Gap Scan before you commit — see exactly what is missing.
- One flat fee per product safety dossier; disclosed pass-through costs for third-party lab tests.
- Flat fee per facility registration (including U.S. Agent designation for foreign facilities).
- Optional annual maintenance plan for listing updates, adverse-event monitoring, and biennial renewals.
FAQ
Questions, answered precisely.
Is MoCRA Cosmetic Compliance & Safety Substantiation Engine a law firm?
No. MoCRA Cosmetic Compliance & Safety Substantiation Engine, a service of Your Deputy, Obuke LLC, provides documentation-completeness and regulatory compliance services. It is not a law firm, does not provide legal advice, and does not represent you in any legal matter. Attorney review is available and recommended for complex or contested matters.
Do you interact with FDA on our behalf?
We prepare and submit documentation as your authorized agent, but you remain the Responsible Person. We do not make legal representations to FDA without your explicit direction.
What makes a pack 'complete'?
Completeness is defined by MoCRA: facility registration, product listing, safety substantiation with qualified expert sign-off, adverse-event reporting procedures, and recordkeeping — all verified against the statute. Deterministic gates enforce each one before release.
How fast is it?
The standard SLA is 15 business days from complete intake to a released pack for standard products. The free Gap Scan is returned much sooner and tells you exactly what is still needed.
How are you priced?
Flat fees per product safety dossier, per facility registration, and per annual maintenance plan. No hourly billing and no percentage of your product revenue.
See what's missing before it costs you a product launch.
Start with a free MoCRA Readiness & Gap Scan. Upload your label and ingredient list and we'll return a compliance gap report against every MoCRA obligation.
Documentation-completeness service · not legal advice · the brand remains the Responsible Person.