World’s largest FDA compliance company is ready on day one, already serving the needs of hundreds.
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HAMPTON, VA, Month Day, 2023 (Distributor) — Registrar Corp, the leading regulatory compliance services, training, and software firm for all things FDA has begun leveraging its extensive Structured Product Labeling (SPL) expertise to assist hundreds of cosmetic companies in submitting critical compliance data through FDA’s new Cosmetics Portal.
“We’ve spent the last 20 years working with FDA systems. We know what it takes to get MoCRA compliance done the right way and set our clients up for long-term success,” said David Lennarz, Co-founder and President of Registrar Corp. “Now that the cosmetics portal is open, we are thrilled to serve the queue of hundreds who have already trusted us to handle their submissions.”
With FDA’s launch of Cosmetics Direct, the new facility registration and product listings portal, businesses are now required to begin complying with the submission guidelines outlined in the Modernization of Cosmetics Regulation Act (MoCRA).
The statutory deadline for facility registration and product listing is still marked for December 29, 2023. However, FDA will exercise enforcement discretion until July 1, 2024, providing a six-month extension.
It is important to remember this delay is specific to facility registration and product listing only. All other statutory requirements that go into effect on December 29, 2023 will be enforced (including adverse event tracking and reporting, safety substantiation, professional use labeling, records access, etc).
“The passage of MoCRA has already made cosmetic compliance more complex than ever and, for those companies where managing and formatting SPL data is new territory, the portal and its use can seem both intimidating and daunting,” Jaclyn Bellomo, Director of Cosmetic Services and Software, said. “We help lift the burden and stress of handling complicated XML and validation requirements from our clients so they can focus on the initiatives that matter most to their business.”
Registrar Corp is already hard at work communicating with FDA and submitting documentation on their clients’ behalf, helping countless companies become MoCRA compliant quickly and easily.
About Registrar Corp
As the world’s largest FDA compliance company, Registrar Corp has spent the last two decades helping over 30,000 companies each year across 190+ countries navigate the complexities of FDA compliance.
From facility registration and cosmetic product listings to adverse event contact and reporting, Registrar Corp knows how to help you navigate and achieve MoCRA compliance with cosmetic solutions including:
- Proper registration of your cosmetic facilities with FDA
- U.S. Agent representation for cosmetic facilities outside the U.S.
- Assistance submitting and managing your cosmetic product listings
- Adverse event collection and reporting
- In-depth cosmetic labeling and ingredient reviews
- Formulation software, online training, and more
If you have questions about FDA requirements or Registrar Corp’s solutions for your industry, contact Registrar Corp at info@registrarcorp.com or call +1-757-224-0177.
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