US Agent

Are you a cosmetic manufacturer and want to sell your products in the United States? Do you want to be sure you meet all the legal requirements? That is where we step in!

With 35 years of global regulatory experience, Obelis is the ideal company to be your US Agent. We offer a one-stop solution for cosmetic regulatory compliance: we ensure your products meet the regulatory requirements so you can lawfully place them on the US market

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What we do as your US Agent

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.

As your US Agent, we:

  • 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

You will also enjoy additional benefits:

  • 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

If you appoint us as your US Agent, we will become your regulatory partner: our mission is to get your cosmetic products on the US market as smoothly as possible.

Don’t let regulatory challenges undermine your business. Contact us today to learn how we can help you.

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Founded in 1988, Obelis is certified by ISO 9001:2015 and ISO 13485:2016. Our team of lawyers, chemists, pharmacists, and other experts represents Europe’s largest centre for CE marking and EC REP services.
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