Stage 01: Trust & Safety
The foundation for MoCRA compliance.
The Challenge
At the "Maker" stage, one contamination issue or adverse reaction can end your brand. You are building your reputation. Customers trust that your products are safe, and with the introduction of MoCRA (Modernization of Cosmetics Regulation Act), the FDA now legally requires you to prove it.
Regulatory Requirements: Safety Substantiation
MoCRA mandates that every brand must have "Safety Substantiation" on file. This means you need data proving your product is not harmful under normal use. You must address two key areas:
- Microbial Contamination: Is the product clean and free from harmful bacteria, yeast, and mold?
- Irritation Potential: Is the formula likely to cause rashes or reactions?
The Still Labs Solution
Microbial QC (USP 61/62)
We screen your batch for total aerobic microbes and specific pathogens. This is essential batch-release data.
3D Skin Irritation (OECD 439)
We use advanced, in-vitro human skin models to determine irritation potential. This provides high-quality, cruelty-free safety data required by MoCRA.
Stage 02: Stability & Validation
Preparing for manufacturing and retail shelves.
The Challenge
Scaling up changes everything. Moving from 1-gallon batches in your studio to 50-gallon batches at a contract manufacturer introduces new risks. You need to ensure your preservative system is robust enough for commercial scale and that your product won't separate, change color, or spoil on a retail shelf.
Regulatory Requirements: Shelf Life & Efficacy
Contract manufacturers and boutique retailers require validation before they take on your product. They need assurance in two primary areas:
- Preservative Validation: Does your preservative system (especially natural alternatives) actually work when challenged with microbes over time?
- Shelf Stability: What is the product's expected shelf life? Retailers will not accept products without this data.
The Still Labs Solution
Preservative Efficacy Test (PET/USP 51)
The "Challenge Test." We intentionally inoculate your product with microbes and monitor it for 28 days to validate that your preservative system is effective. Mandatory for water-based products.
Accelerated Stability (90 Day)
We use environmental chambers to simulate 1-2 years of shelf life in just 90 days. We monitor pH, viscosity, color, and odor to predict how the product will age.
Stage 03: Clinical Claims & Retail
Securing the deal with Target and Sephora.
The Challenge (The Technical Equity Gap)
Major retail is the big league. Target, Sephora, and Ulta have rigorous compliance audits. You are competing with conglomerates (L'Oréal, Estée Lauder) who have extensive clinical data. To win shelf space, your marketing claims must be backed by scientific proof, and you must meet stringent safety standards like California's Prop 65.
Regulatory Requirements: Potency & Purity
To pass major retail audits and substantiate "clinical" marketing, you must provide data across multiple complex areas:
- Potency Verification: If you claim "20% Vitamin C," you must prove the exact percentage in the final formula using analytical chemistry.
- Extensive Stability: Retailers often require data simulating 2-3 years of shelf life.
- Heavy Metal Screening (Prop 65): Products sold nationally must be screened for trace heavy metals (lead, arsenic, mercury) using ICP-MS.
The Still Labs Solution (Vertical Integration)
HPLC-MS Potency Verification
High-Performance Liquid Chromatography-Mass Spectrometry. We verify the exact concentration of active ingredients (Retinol, Niacinamide, Vitamin C) to validate your clinical claims.
Managed Prop 65 Testing
We manage our trusted partner network for ICP-MS Heavy Metal screening. We handle the logistics and interpret the data, providing you with one clear report.