Global Regulatory Compliance

Your Authorized Representative & Responsible Person

At Obelis, we specialize in ensuring regulatory compliance for Medical Devices, Cosmetics, and other industries. Our Authorized Representative and Responsible Person services provide expert guidance for swift and safe market entry, tailored to meet the diverse needs of businesses. We span regulations in the EU, UK, US, Switzerland, and beyond to support your compliance needs effectively.

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Explore Our Global Services

Select your industry and your region to discover how we help your products enter and thrive in international markets.

Authorised Representative & Responsible Person

We provide Authorised Representative and Responsible Person services to help ensure your medical devices comply with local regulations. We act as your official contact with regulatory authorities, handle documentation, ensure all regulatory requirements are fulfilled and ensure post-market obligations are met.

European Union United Kingdom Switzerland

Responsible Person for Cosmetics

We offer Responsible Person services to ensure your cosmetic products comply with all applicable regulations. We verify product safety, review labels and documentation, handle notifications to the authorities and monitor post-market activities. Obelis ensures that only safe and compliant products reach consumers, protecting both your brand and customer trust.

European Union Canada United Kingdom

Registration & US Agent

We provide registration and US Agent services to help your medical and cosmetic products comply with FDA requirements. We serve as the official points of contact with the FDA, assist with product registration, and ensure smooth communication during inspections or inquiries. Our support helps you confidently access the US market while staying fully compliant with regulatory obligations.

Medical Cosmetics

Why Obelis?

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.

About us
Founded in 1988, we are among Europe’s largest centres for advisory and representative services. We are proud to have helped over 7,000 manufacturers from over 90 countries address their regulatory challenges.
We are certified by ISO 9001:2015 and ISO 13485:2016.
We are members of professional associations and more than 10 European Commission working groups.
Our team consists of lawyers, chemists, pharmacists, and other experts. Our close-knit culture has been certified by the Great Place to Work Survey 2022-23.
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Our Global Locations

European Union

Tel: +32 2 732 5954
Fax: +32 2 732 6003
hello@obelis.net

United Kingdom

Tel: +44 1491 378 012
hello@obelis.net

United States

Tel: +1 513 740-8559
hello@obelis.net

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