• Formulation, labels, claims review
• Packaging recycling requirements support
• Product Information File compilation 
• Safety Assessment Report
• Free Sales Certificates
• Laboratory testing
• CPNP / SCPN notification

• Formulation, labels, and technical documentation check
• Facilities and products registrations
• Safety substantiation support
• Adverse events evaluation and record
• Serious adverse events report and record
• Recall, suspensions, and inspections support
• Communication management with the FDA

We register your products in EU & UK in 3 working days!

Any compliance challenge? 

EU & UK

Why Obelis? 

Experience

Founded in 1988, we are among Europe’s largest centres for advisory and representative services.

ISO Certification

We are certified by ISO 9001:2015 and ISO 13485:2016.

Commitment to Compliance

We have helped over 3,000 manufacturers from over 60 countries address their regulatory challenges.

Proximity to EU Institutions

We are members of professional associations and more than 10 European Commission working groups.

International Network

Obelis International Offices (OIO) comprise independent partners providing solutions in other global markets.

Our Team

Our team consists of lawyers, chemists, pharmacists, and other experts. 

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Obelis Group

Boulevard Brand Whitlock 30, 

Brussels, 1200, Belgium

Tel: +32 (0)2 732 59 54

sales@obelis.net

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Industries

Medical devices

In-vitro diagnostics

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Information platforms

Mdlaw.eu

Coslaw.eu

Prodlaw.eu

USA

"We feel very supported!"

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.

​

Javier Aravena

Regulatory Affairs Manager

"Their expert team helped us to avoid possible regulatory complications"

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.

​

Florian L. Gablenz 

Business Development Manager 

" Successfully launched our devices into multiple European countries"

 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.

​

Ran Amos

VP of Quality Assurance & Regulatory Affairs

Compliance Success stories