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 across global regions. They focus on ensuring products meet the requirements for entry into various markets.
**Expertise & scope**
* Market access for Medical Devices, Cosmetics, Food Supplements, Toys, and Motor Vehicles.
* Regulatory compliance services for the EU, UK, US, and Switzerland.
**Reputation / proof points**
* Coverage for the US market.
* Services available in English.
Obelis Group is a regulatory compliance partner specializing in market access across global regions. They focus on ensuring products meet the requirements for entry into various markets.
**Expertise & scope**
* Market access for Medical Devices, Cosmetics, Food Supplements, Toys, and Motor Vehicles.
* Regulatory compliance services for the EU, UK, US, and Switzerland.
**Reputation / proof points**
* Coverage for the US market.
* Services available in English.
Additional information
Obelis Group facilitates market access by navigating complex regulatory landscapes. Their expertise spans multiple product categories, ensuring compliance with regional requirements. For the US market, they provide essential support to help companies establish their presence and distribute products legally. Their services are delivered in English, streamlining communication for international clients seeking to enter or operate within the US.
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”
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
- Companies seeking market access for medical devices, cosmetics, food supplements, toys, and motor vehicles.
- Businesses needing regulatory compliance support in the EU, UK, US, and Switzerland.
How engagement typically works
- Partnering for global regulatory compliance.
- Specializing in market entry strategies.
Typical deliverables
- Regulatory compliance assessments.
- Market access facilitation.
- Support for US market entry.
Good to know
- Best when requiring specialized knowledge of EU, UK, US, and Swiss regulations.
HQ:
Brussels, BE
Languages:
English
Timezones:
America/New_York
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
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
