The Modernization of Cosmetics Regulation Act (MoCRA) introduced new legal obligations for cosmetic manufacturers and brand owners selling products in the United States.
Every cosmetic must now have clear, well-organized documentation demonstrating that it is safe, properly labeled, manufactured under sanitary conditions, and compliant with FDA requirements.

Our U.S. Cosmetic Product Dossier Creation service provides all the necessary documents, evidence, and structure you need to meet MoCRA’s documentation standards — similar in concept to the EU Product Information File (PIF), but tailored to U.S. regulations.

We create a complete, audit-ready dossier that ensures your brand is prepared for FDA inspection or verification at any time.

What the U.S. Product Dossier Includes

Each dossier is structured to cover the full scope of FDA expectations under MoCRA:

1. Administrative and Product Identification

• Product name, function, and category

• Responsible Person details (manufacturer, importer, or distributor)

• Product labeling, artwork, and claims review

• Facility registration references

2. Product Composition

• Full ingredient list with INCI names and concentrations

• Ingredient source documentation and supplier data

• Restrictions and regulatory checks for each component

• Fragrance and flavor documentation where applicable

3. Safety Substantiation File

• Toxicological profile for each ingredient

• Exposure and risk assessment

• Margin of Safety (MoS) calculations

• Final Safety Substantiation Statement

4. Manufacturing and Quality Information

• Description of manufacturing process and controls

• GMP conformity statement (aligned with FDA expectations and ISO 22716 principles)

• Microbiological controls and batch traceability

• Record of quality testing and packaging compatibility data

5. Stability and Shelf-Life Data

• Stability and storage test summaries

• Packaging compatibility results

• Period After Opening (PAO) or shelf-life justification

6. Labeling and Claims Compliance

• Review of product labeling to ensure compliance with FDA cosmetic labeling rules (21 CFR 701)

• Verification of ingredient declarations, warnings, and product identity

• Marketing claims review to ensure that no drug-like claims are made

7. Supporting Documentation

• Certificates of Analysis (COA) and SDS for key ingredients

• IFRA, allergen, or fragrance documentation as available

• Safety and performance test reports (optional)

• FDA submission confirmations (facility registration and product listing)

Why This Dossier Is Important

Creating a structured dossier helps you:

• Demonstrate compliance with MoCRA and FDA regulations

• Maintain transparency and traceability across your supply chain

• Provide immediate access to documentation if FDA requests inspection

• Protect your brand from costly enforcement actions or recalls

• Strengthen credibility with partners, distributors, and retailers

A complete dossier shows that your company has implemented due diligence in safety, quality, and labeling — essential for U.S. market access.

Who Needs This Service

• European or international brands exporting cosmetics to the United States

• U.S. manufacturers looking to organize and standardize compliance documentation

• Private labelers and distributors managing multiple product lines under one responsible entity

• Regulatory consultants or importers acting as the Responsible Person under MoCRA

What You Receive

• Full U.S. Cosmetic Product Dossier in electronic format (PDF or Word)

• All documents indexed, cross-referenced, and stored in logical structure

• Optional add-ons for translations, updates, or additional formulations

• FDA inspection-ready documentation and long-term archival version

Our Process

1. Data Collection — You provide product formula, label, and manufacturing information.

2. Compliance Review — We verify data completeness, labeling, and regulatory compliance.

3. Dossier Compilation — Our team compiles and structures the full dossier according to MoCRA expectations.

4. Quality Check & Delivery — You receive a complete, ready-to-submit file along with a verification summary.

Why Choose Us

• Experts in both EU and U.S. cosmetic compliance

• Deep understanding of MoCRA, FDA labeling rules, and toxicological documentation

• Clear communication and transparent process

• Professional, inspection-ready dossiers prepared by regulatory specialists