FDA MoCRA Cosmetics Direct Portal Now Open

[Georgia, USA – Dec 19, 2023] – As the deadline for electronic registration under the Modernization of Cosmetics Regulation Act (MoCRA) approaches, numerous cosmetic companies brace themselves for the shift towards digital compliance. Quality Smart Solutions, a prominent FDA regulatory compliance solutions provider with substantial expertise in the cosmetics domain, is primed to assist manufacturers through this pivotal transition.

With the FDA’s Cosmetics Direct portal now open, the process of electronic registration and listing may appear complex. However, Quality Smart Solutions pledges to streamline this journey. Leveraging over two decades of experience aiding more than 2,000 clients spanning diverse industries, we grasp the distinct hurdles encountered by cosmetic manufacturers.

Although the statutory cut-off for facility registration and product listing remains December 29, 2023, the FDA has extended enforcement discretion until July 1, 2024, allowing a six-month extension.

It is imperative to note that this extension solely pertains to facility registration and product listing. All other statutory obligations effective from December 29, 2023, will be rigorously enforced, encompassing adverse event monitoring and reporting, safety validation, professional use labeling, records accessibility, among others.

“We provide a comprehensive array of services tailored specifically for the cosmetic industry,” remarked Andrew Parshad, CEO of Quality Smart Solutions. “From MoCRA compliance assessments and data preparation to expert training and continuous support, our aim is to facilitate a seamless transition to the new electronic system.”

Our adept team stands prepared to assist in every facet of the process, including:

  • Identification of potential gaps and ensuring a smooth transition to the Cosmetics Direct portal
  • Accurate registration of cosmetic facilities with the FDA
  • U.S. Agent representation for cosmetic facilities located outside the U.S.
  • Aid in submitting and managing cosmetic product listings
  • Collection and reporting of adverse events
  • Detailed reviews of cosmetic labeling and ingredients
  • Provision of formulation software, online training, and ongoing support

For additional details and comprehensive information on MoCRA compliance and cosmetic regulation, visit our website at https://qualitysmartsolutions.com/mocra-cosmetic-regulation/.

Should any inquiries about FDA requirements or regulatory guidance arise, please reach out to Quality Smart Solutions at info@qualitysmartsolutions.com or via our Toll-Free number 1-800-396-5144.

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