The Modernization of Cosmetics Regulation Act (MoCRA) has introduced the most significant changes to the U.S. cosmetic industry. FDA CertPRO provides end-to-end compliance solutions, ensuring your cosmetic brand meets FDA MoCRA requirements quickly and effortlessly.
Register with FDA
Navigating the evolving landscape of U.S. cosmetic regulations is crucial for businesses aiming to ensure compliance and maintain consumer trust. The Modernization of Cosmetics Regulation Act (MoCRA) has introduced significant changes, and at Consult CertPRO, we offer comprehensive solutions to help cosmetic companies align with these new requirements.
We cater to a diverse range of cosmetic businesses, from emerging brands to established industry leaders, simplifying the compliance process to ensure your products are distributed confidently and safely. Our services include:
All cosmetic manufacturing facilities are now required to register with the FDA. We facilitate this process and offer U.S. Agent services for non-U.S. facilities, ensuring seamless communication with regulatory authorities.
Each cosmetic product must be listed with the FDA. Our team streamlines this process, saving you time and resources, and minimizing the complexities involved in self-registration.
MoCRA mandates the collection, investigation, and reporting of adverse events. Our Adverse Events Management software ensures you remain compliant by efficiently managing these reports.
With updated labeling requirements under MoCRA, our specialists conduct thorough reviews to ensure your product labels meet the latest FDA standards, preventing potential market setbacks.
Accelerate your product development while maintaining compliance using Cosmetri, our GMP and cosmetic formulation software designed to uphold quality and regulatory standards.
Equip your quality assurance and compliance teams with the knowledge they need through our expert-led online training courses covering GMP, MoCRA, ISO 22716, and Good Laboratory Practices (GLP).
Owners, operators, or agents in charge of domestic or foreign facilities that manufacture, process, pack, or hold cosmetic products for U.S. consumption must register their facilities with the FDA, unless exempt under specific regulations. This requirement applies to domestic facilities regardless of whether their products enter interstate commerce.
Certain facilities may be exempt from FDA registration; however, specific exemptions depend on various factors outlined in the Code of Federal Regulations. It's essential to consult with regulatory experts to determine if your facility qualifies for an exemption.
At Consult CertPRO, we are dedicated to guiding you through these regulatory changes, ensuring your cosmetic products comply with all necessary FDA requirements for successful market entry and continued consumer trust.