Cosmetics Regulatory Services

MoCRA Facility Registration via Cosmetics Direct

We register your manufacturing or processing facilities with FDA through the Cosmetics Direct portal to meet MoCRA deadlines.

MoCRA Cosmetic Product Listing

We submit product listings for each cosmetic SKU, including ingredient details, to keep your full portfolio compliant.

Safety Substantiation Documentation

We compile the safety data and documentation needed to substantiate your product's safety under FDA requirements.

FDA Cosmetic Labeling Review (21 CFR 701)

We review your labels for compliance — ingredient declarations, required warnings, and net quantity statements.

Ingredient Safety Assessment — FDA Prohibited/Restricted Lists

We screen your formulas against FDA's prohibited and restricted ingredient lists to catch compliance issues early.

Health Canada Cosmetic Notification Form (CNF) Submission

We prepare and submit CNFs to Health Canada within the required 10-day window before your product goes on sale.

Health Canada Cosmetic Ingredient Hotlist Screening

We check your ingredients against Health Canada's Hotlist to identify prohibited or restricted substances for the Canadian market.

Bilingual EN/FR Canadian Label Compliance

We ensure your Canadian labels meet bilingual requirements, with proper ingredient declarations in both English and French.

Dual-Market Regulatory Strategy (U.S. + Canada)

We develop a coordinated compliance strategy to launch your cosmetic products in both markets efficiently.

Adverse Event Reporting & Serious AE Procedures

We help you establish reporting procedures and manage serious adverse event notifications to FDA as required by MoCRA.

GMP Compliance for Cosmetic Manufacturing

We assess your manufacturing practices and guide improvements to align with FDA and Health Canada GMP expectations.