Your Trusted Partner ForÂ
MoCRA Regulatory Compliance
FDA Registration, Product Listing, Deadlines and US Agent services.Â
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) grants the U.S. FDA increased authority and supervision over the cosmetics industry. As the world's largest, most trusted U.S. Regulatory Compliance partner, Obelis Group can help your cosmetic company meet U.S. FDA requirements.
Client Success StoriesÂ
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I encourage companies to seek compliance before putting their products on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.​
 We successfully launched our products into multiple European countries.
Ran Amos
VP of Quality Assurance & Regulatory Affairs
We were under huge time and cost pressure for a new OEM product line launch and we relied on Obelis. It was the right decision, their expert team helped us to avoid possible regulatory complications.
Their expert team helped us to avoid possible regulatory complications
Florian L. GablenzÂ
Business Development ManagerÂ
We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make it seem so easy.
 We feel very supported!
Javier Aravena
Regulatory Affairs Manager
As your US Agent, Obelis will serve as the primary point of contact between FDA and your company.
US Agent contact point/ FDA
Make sure your labels are compliant before being placed on the market.
Labeling Review
Each cosmetic product must have adequate substantiation of its safety. We help you to collect the necessary documentation. Â
Safety Substantiation
Get support for the electronic submission portal for product listing and facility registration.
Cosmetics Direct Registrations
Make product listing quick & easy. Meet US FDA cosmetics requirements (US and non-US) with Obelis.
Product Listing
Registration of facility for manufacturers and processors (US and non-US) with FDA.
Facility Registration
We help you navigate the adverse event reporting requirements outlined in MoCRA.
Serious Adverse Events Reporting
The spotlight on product safety is shining brighter than ever. How recall ready are you?Â
Support on Product Recalls by FDA
We receive, evaluate, and record adverse events.
Adverse events recording
Obelis USA solutions for MoCRA compliance
