Your Agent and Consultant in the US
Stringent regulations from the CPSC, FDA, and more make entering the U.S. market complex. We ensure your products meet all standards, avoiding costly delays and recalls.
Industries
Services
United States
Failing to comply with US regulations can have severe consequences for businesses. Secure your investment with our expert regulatory support.
Non-compliance can lead to significant fines and penalties from federal and state regulatory agencies. These fines can range from thousands to millions of dollars, depending on the severity and frequency of the violations.
Companies may face lawsuits from customers, competitors, or government agencies for damages, unfair business practices, or other claims related to non-compliance.
News of regulatory violations can damage a company’s brand image and reputation, leading to loss of customer trust and loyalty, difficulty attracting investors, and increased scrutiny from regulators.
Non-compliance can result in suspension or revocation of licenses, permits, or certifications, leading to business disruptions and potential closures.
In some cases, serious non-compliance with certain regulations, such as environmental or safety laws, can lead to criminal charges against company executives and employees.
Partner with us
Thorough Compliance
We meticulously guide you through the complex US regulatory landscape, ensuring your products meet all requirements.
Risk Mitigation
We identify and address potential compliance issues early, protecting your investment and minimizing risk.
Peace of Mind
Focus on growing your business while we handle the regulatory complexities, giving you the confidence to launch successfully in the US.
What clients are saying
“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”
“Obelis helped us navigate complex regulatory landscapes, ensuring we met all legal and industry-specific obligations. Obelis deeply understands the cosmetic regulatory landscape and they have provided all the necessary support”
“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”
Our deep and long-standing experience with Swiss, EU and UK compliance frameworks makes us the best choice to support your products’ path towards compliance in these territories.
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Europe’s leading center for regulatory consultancy and representative services
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ISO 9001:2015 and ISO 13485:2016 certified
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Since 1988, we supported 3,000+ manufacturers from 60+ countries
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Members of professional associations and European Commission working groups
About us
