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 focused on global market access. They specialize in navigating complex regulatory landscapes for various industries.
**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 the US market.
Obelis Group is a regulatory compliance partner focused on global market access. They specialize in navigating complex regulatory landscapes for various industries.
**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 the US market.
Additional information
For companies seeking to enter the US market, Obelis Group acts as the FDA U.S. Agent, fulfilling a critical regulatory requirement. This role involves maintaining communication with the FDA on behalf of the foreign manufacturer, ensuring timely dissemination of information and facilitating compliance with U.S. regulations. Their services are designed to streamline the market entry process for medical devices and other regulated products, providing a dedicated point of contact within the United States.
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, and 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 the FDA U.S. Agent for foreign manufacturers.
Source
“Obelis Group is your trusted partner for global regulatory compliance”
Certifications & Trust Signals
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Trusted partner for global regulatory compliance.
Source
“Obelis Group is your trusted partner for global regulatory compliance”
Buyer Snapshot
Best for
- Foreign manufacturers needing an FDA U.S. Agent.
- Companies seeking market access for medical devices, cosmetics, and food supplements in the US.
How engagement typically works
- Retainer-based services for ongoing regulatory representation.
- Direct communication and support for FDA interactions.
Typical deliverables
- FDA U.S. Agent services.
- Regulatory strategy and consultation for US market entry.
- Facilitation of communication with FDA.
Good to know
- Best when requiring a dedicated US-based representative for FDA compliance.
HQ:
Brussels, BE
Languages:
English
Timezones:
America/New_York
Claim status:
Listed
Services & Capabilities
Best 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
Implied through FDA U.S. Agent role
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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