New Adverse Event Reporting software and services help save cosmetic companies time and effort in complying with updated FDA regulations.
Read the release on Newswire.
HAMPTON, VA, September 28, 2023 — Registrar Corp, the leading regulatory compliance services, training, and software firm has introduced their new Adverse Event Reporting software to help cosmetic companies simplify FDA requirements.
This new software helps businesses meet essential FDA regulations that are being instituted as a result of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
“With this historic change to industry regulations, cosmetic companies are now required to collect, maintain, and submit reports on adverse events to FDA. Our software acts as a bridge for clients, their customers, and FDA.” — Jaclyn Bellomo, Director of Cosmetic Services & Software.
Registrar Corp’s New Cosmetic Adverse Event Services & Software
With this new offering, Registrar Corp serves manufacturers, brand owners, and more, as a U.S. Contact for the proper gathering and forwarding of consumer complaints as required by the U.S. Food and Drug Administration (FDA).
Registrar Corp’s Adverse Event Reporting & Contact Services and Software save companies time and effort by helping them comply with FDA, so they can focus on marketing and selling their products in the U.S. and beyond.
As cosmetic companies’ U.S. Contact for cosmetic adverse event reporting, Registrar Corp:
- Authorizes the use of their contact information on cosmetic labels for adverse event purposes in the form of a URL
- Receives reports of serious adverse events on the company’s behalf
- Forwards consumer complaints
- Maintains easy online communication
- Assures compliance with FDA
For $995 a year, the Adverse Event Essentials Package includes reporting for unlimited products, QR code functionality, and a branded URL to collect consumer complaints.
“Our solution will assist companies in gathering the exact data as required by FDA. Should FDA change what is required, our solution will adjust accordingly to be sure you remain in compliance.” — David Lennarz, Co-Founder and President.
Customizable Options to Meet Companies’ Individual Needs
Serving over 30,000 businesses each year, Registrar Corp has defined what it means to make compliance quick and easy. With simple and customizable technology for adverse event reporting and access to regulatory specialists with over 20 years of experience working with FDA, cosmetics businesses can comply with FDA’s adverse event regulations with ease.
Registrar Corp is proud to add this offering for cosmetics to its existing Adverse Event Reporting Services for the medical device and dietary supplement industries.
Adverse Event Reporting Requirements
Under new regulations, a responsible person is required to report serious adverse events associated with the use of cosmetic products in the U.S. to FDA. The responsible person must include a copy of the label on or within the retail packaging of such cosmetic product.
If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, they are required to submit this new information to FDA within 15 business days.
Registrar Corp’s Additional Compliance Services
Registrar Corp provides a variety of comprehensive compliance services for cosmetic, medical device, dietary supplement, food and beverage, and drug establishments. These include, but are not limited to:
- FDA Registration and Renewal
- Automated Compliance Software
- Online Training
- Label, Ingredient, and Product Review
- Detention and Import Alert Assistance
Now with Registrar Corp’s Adverse Event Reporting & Contact Services and Software, companies have even more ways to achieve FDA compliance.
About Registrar Corp
Since 2003, Registrar Corp has been a leading resource for FDA compliance, offering tech-enabled services, fully online compliance training, software product solutions, and proprietary data. Headquartered in Hampton, Virginia, Registrar Corp has 19 worldwide offices and assists over 30,000 companies each year with FDA compliance.
If you have questions about FDA requirements or Registrar Corp’s solutions for Adverse Events, contact Registrar Corp at info@registrarcorp.com or call +1-757-224-0177.
