You make it
Cosmetic manufacturers and contract fillers. GMP, documentation and audit readiness that holds up to inspection.
Your compliance bestie
Compliance, simplified.
MoCRA, ISO 22716, and ISO 9001 readiness for beauty brands and manufacturers, led by someone who has spent 15 years inside FDA-regulated quality systems and knows beauty from the brand owner's side.
15+
Years in FDA-regulated quality systems
MoCRA
Registration, listing, safety and labeling
ISO 22716
Cosmetic good manufacturing practice
ISO 9001
Quality management systems
01 — Why now
The rules for cosmetics have changed.
The Modernization of Cosmetics Regulation Act (MoCRA) is the biggest expansion of FDA authority over cosmetics since 1938.
Certain small businesses may qualify for exemptions from some MoCRA requirements, but safety substantiation, labeling, and serious adverse event reporting still apply. And more retailers are asking suppliers for proof of GMP compliance.
Now federal requirements
Facility registration
Product listing
Safety substantiation
Adverse event reporting
New labeling rules
02 — Who we serve
Where you fit, and how we help.
ISO 22716 GMP readiness →
You brand it
If your name is on the label, you're the responsible person, even if someone else fills the bottles.
You repackage it
Relabelers and repackagers. Often overlooked, still accountable. We'll clarify what follows your name.
You're just starting
Certain small businesses may qualify for exemptions from some MoCRA requirements. Safety, labeling, and adverse-event responsibilities still apply.
You manufacture beyond beauty
General manufacturers building ISO 9001 quality systems, preparing for audits or assembling EU technical files.
Not sure where you fit?Book a free 15-minute intro call →
03 — What we do
Clarity first. Then a plan you can actually follow.
01
Assess
We find out exactly where you stand and give you a written summary of what applies to your products, facility and sales, and where the gaps are.
02
Build
We create what's missing: registration and listing plans, safety files, adverse-event procedures, label reviews, SOPs and training.
03
Stay ready
No cookie-cutter packages. Internal audits and ongoing support so you're ready when a retailer, auditor or the FDA asks.
If your name is on the label, you're the responsible person. I'll make sure you're ready for that.
Shelley Carrillo, Founder
04 — Stellify Academy