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 across the EU, UK, US, and Switzerland. They focus on ensuring products meet the regulatory requirements of these diverse markets.
**Expertise & scope**
* Facilitating market access for Medical Devices, Cosmetics, Food Supplements, Toys, and Motor Vehicles.
* Providing regulatory compliance solutions for the US market.
* Expertise in navigating international regulatory landscapes.
**Reputation / proof points**
* Established presence in global regulatory compliance.
Obelis Group is a regulatory compliance partner specializing in market access for various industries across the EU, UK, US, and Switzerland. They focus on ensuring products meet the regulatory requirements of these diverse markets.
**Expertise & scope**
* Facilitating market access for Medical Devices, Cosmetics, Food Supplements, Toys, and Motor Vehicles.
* Providing regulatory compliance solutions for the US market.
* Expertise in navigating international regulatory landscapes.
**Reputation / proof points**
* Established presence in global regulatory compliance.
Additional information
Obelis Group serves as a crucial partner for companies seeking to enter and operate within regulated markets like the US. Their role as a U.S. Agent is vital for foreign manufacturers to comply with FDA requirements, ensuring a point of contact for official communications and facilitating smoother market entry. Understanding the specific regulatory pathways for product categories such as medical devices or cosmetics is key to their service offering.
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, and other industries”
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Provides regulatory compliance solutions across the EU, UK, US, and Switzerland.
Source
“across the EU, UK, US, and Switzerland.”
Certifications & Trust Signals
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Acts as a trusted partner for global regulatory compliance.
Source
“Obelis Group is your trusted partner for global regulatory compliance”
Buyer Snapshot
Best for
- Foreign manufacturers seeking US market access
- Companies needing a US FDA Agent
How engagement typically works
- Regulatory partnership
- Compliance support
Typical deliverables
- US FDA Agent services
- Market access facilitation
Good to know
- Best when requiring a dedicated US point of contact for regulatory matters.
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 US Agent role for FDA compliance
Recall Support
Implied through US Agent role for FDA compliance
Inspection Support
Implied through US Agent role for FDA compliance
Emergency Contact24x7
Not explicitly stated
US Entity State
Not explicitly stated
Onboarding Steps
Not explicitly stated
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