Each engagement starts with where you are today — audit findings, a new market, or a facility preparing to register — and ends with a clear, practical plan.
Hands-on audit support for facilities that need to demonstrate — not just assert — good manufacturing practice.
End-to-end support for MoCRA and existing FDA requirements, so nothing falls through the cracks as deadlines pass.
Guidance for brands entering or maintaining a presence in the European Union and United Kingdom.
Documentation and process work that holds up under audit, not just on paper.
Integrated support for brands entering a new market, bringing quality and regulatory considerations together in a single plan.
Practical training that gives teams the working knowledge to support compliance day to day.
The Modernization of Cosmetics Regulation Act (MoCRA) was signed into law on December 29, 2022 — the first major reform of U.S. cosmetic law since 1938. Its requirements are phasing in on a defined timeline.
Manufacturers must substantiate product safety and maintain adequate records. Responsible persons must keep adverse event records for six years (three for small businesses) and report serious adverse events to the FDA within 15 business days.
Facilities manufacturing or processing cosmetics for U.S. distribution must register with the FDA and renew every two years. Responsible persons must list each marketed product, including ingredients and facility details.
Labels must include contact information for reporting adverse events and disclose fragrance allergens. Professional-use products must state their restriction to licensed professionals.
The FDA is establishing mandatory GMP regulations for cosmetic facilities, expected to align closely with ISO 22716 principles.
Effective dates reflect the general MoCRA framework and are provided for informational purposes only. Contact us to confirm how they apply to your facility or products.
Share a few details about your product, facility, or target markets and we’ll recommend the right starting point.
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