The new US law on cosmetic products, MoCRA, introduces several requirements for cosmetic manufacturers and their products to enter the US market. In particular, it establishes that facilities based outside the United States must have an in-country representative: a US Agent. While non-USA brand owners should have a domestic contact point, which can be your US Agent.
- Check your formulas, labels, and technical documentation to ensure compliance
- Advice on establishment of product safety substantiation
- Hold safety substantiation documentation
- Register your facilities and products
- Maintain the above registrations up-to-date
- Advise you on regulatory requirements
- Receive, evaluate, and record adverse events
- Report and record serious adverse events
- Represent you before the FDA
- Support you in case of recalls, registration suspensions, inspections
- Inform you about regulatory news
- A dedicated consultant always at your disposal
- An international network that can help you access other markets, like the EU and UK
- Training on MoCRA and cosmetic regulations
- Access to our Information Platform on cosmetic products, COSlaw
- And much more
Compliance Success Stories
“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 is seem so easy.”
“We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications.”
“I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.”
