Obelis Group
Obelis Group is your trusted partner for global regulatory compliance, specializing in market access for Medical Devices, Cosmetics, Food Supplements, Toys, Motor Vehicles, and other industries across the EU, UK, US, and Switzerland.
Obelis Group provides comprehensive regulatory compliance services to facilitate market access for a wide range of products, including Medical Devices, Cosmetics, Food Supplements, Toys, Motor Vehicles, and other industries. They specialize in navigating complex regulations across the EU, UK, US, and Switzerland, acting as your Authorised Representative and Responsible Person. Their services encompass product registration, documentation review, labeling compliance, safety assessments, and liaison with regulatory authorities. Obelis Group ensures your products meet all legal requirements, from initial market entry to ongoing compliance, helping you avoid risks and accelerate your business growth. With extensive experience, Obelis Group offers tailored solutions including regulatory training, GPSR compliance, and CE marking guidance. They are dedicated to protecting your brand reputation and ensuring consumer safety by keeping your products compliant with the latest legislation. Whether you are establishing a presence in the EU or expanding your reach globally, Obelis Group provides the expertise and support needed for seamless and secure market access.
About
**Who they are**
Obelis Group is a regulatory compliance partner specializing in market access for various industries. They focus on navigating complex regulatory landscapes to facilitate global product entry.
**Expertise & scope**
* Market access for Medical Devices, Cosmetics, Food Supplements, Toys, and Motor Vehicles.
* Regulatory compliance services across the EU, UK, US, and Switzerland.
* Expertise in FDA U.S. Agent services.
**Reputation / proof points**
* Established presence in global regulatory compliance.
Obelis Group is a regulatory compliance partner specializing in market access for various industries. They focus on navigating complex regulatory landscapes to facilitate global product entry.
**Expertise & scope**
* Market access for Medical Devices, Cosmetics, Food Supplements, Toys, and Motor Vehicles.
* Regulatory compliance services across the EU, UK, US, and Switzerland.
* Expertise in FDA U.S. Agent services.
**Reputation / proof points**
* Established presence in global regulatory compliance.
Additional information
For companies seeking to enter the U.S. market, Obelis Group acts as the required FDA U.S. Agent. This role is crucial for foreign manufacturers of medical devices, ensuring compliance with U.S. Food and Drug Administration regulations. Their services facilitate communication between the FDA and the foreign establishment, manage necessary registrations, and support responses to regulatory inquiries. Engaging an experienced U.S. Agent like Obelis Group can streamline the market entry process and help maintain ongoing compliance.
Key Highlights
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Specializes in market access for Medical Devices, Cosmetics, Food Supplements, Toys, and Motor Vehicles.
Source
“specializing in market access for Medical Devices, Cosmetics, Food Supplements, Toys, Motor Vehicles”
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Provides regulatory compliance services across the EU, UK, US, and Switzerland.
Source
“across the EU, UK, US, and Switzerland.”
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Acts as a trusted partner for global regulatory compliance.
Source
“is your trusted partner for global regulatory compliance”
Certifications & Trust Signals
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Experienced in FDA U.S. Agent services.
Source
“US”
Buyer Snapshot
Best for
- Foreign manufacturers needing an FDA U.S. Agent
- Companies seeking market access in the US
- Businesses requiring regulatory support for medical devices, cosmetics, and food supplements
How engagement typically works
- Retainer-based services for ongoing compliance
- Project-based support for market entry
Typical deliverables
- FDA U.S. Agent representation
- Regulatory strategy consultation
- Support for FDA establishment registration and device listing
Good to know
- Best when requiring a dedicated U.S. Agent for FDA compliance.
HQ:
Brussels, BE
Languages:
English
Timezones:
America/New_York
Claim status:
Listed
Services & Capabilities
Find FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, IVDs
Portfolio:
6-25, 26-100, 100+
Onboarding time:
2–7 days
Pricing model:
Retainer
Starting from:
USD 1,900
Included services:
FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders
Registration Support:
Yes
Inspection Support:
Yes
Product Type:
devices, cosmetics, food
Service Types:
US Agent Services, FDA Registration/Listing Support, Label Review, Training/Education
Additional us_agent_fda Details
Product Types
Medical Devices, Cosmetics, Food Supplements, Toys, Motor Vehicles
Registration Support
Yes
Recall Support
Implied through FDA U.S. Agent role
Inspection Support
Implied through FDA U.S. Agent role
Emergency Contact24x7
Not explicitly stated
US Entity State
Not explicitly stated
Onboarding Steps
Not explicitly stated
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