Obelis Group
★★★★★
4.2
/ 5
•
20 reviews
Obelis Group is your trusted partner for global regulatory compliance, specializing in market access for cosmetics, medical devices, and other industries across the EU, UK, US, Canada, and Switzerland.
Obelis Group offers comprehensive regulatory compliance services to facilitate swift and safe market entry for your products worldwide. Specializing in Medical Devices, Cosmetics, and other industries, they provide expert guidance as an Authorized Representative and Responsible Person. Their services span regulations in the EU, UK, US, Switzerland, and Canada, ensuring your products meet diverse international requirements. For the cosmetics industry, Obelis Group provides tailored solutions including Responsible Person services, PIF review, CPNP notifications, label reviews, and product safety reports for markets like the EU, UK, US, and Canada. They also offer US Agent services and FDA facility/FEI registration to navigate the complexities of the US market under MoCRA. With deep experience in EU, UK, and Swiss compliance frameworks, Obelis Group is well-equipped to support your product's journey to market. They act as your official contact with regulatory authorities, manage documentation, and ensure post-market obligations are met, protecting your brand and consumer trust.
About
**Who they are**
Obelis Group is a regulatory compliance partner specializing in market access for cosmetics, medical devices, and other industries across the EU, UK, US, Canada, and Switzerland. They offer expert guidance for swift and safe market entry.
**Expertise & scope**
* EU Cosmetics Responsible Person services
* Formula & Product Information File (PIF) Review
* CPNP Notification
* Label Review
* Product Safety Report
* Lab Testing
* Adverse Events Reporting
* UK Responsible Person services
* SCPN Notification
* US Agent services (FDA Facility & FEI Registration, Cosmetic Product Listing)
* Canadian Responsible Person services (Cosmetic Notification Forms, bilingual labelling)
* Turkish Responsible Person services (aligned with EU Cosmetics Regulation)
* Regulatory trainings for cosmetics and medical devices, available online or in-house
**Reputation / proof points**
* Specializes in market access for cosmetics, medical devices, and other industries.
* Offers compliance services globally, making them an ideal choice for manufacturers marketing in multiple global markets.
Obelis Group is a regulatory compliance partner specializing in market access for cosmetics, medical devices, and other industries across the EU, UK, US, Canada, and Switzerland. They offer expert guidance for swift and safe market entry.
**Expertise & scope**
* EU Cosmetics Responsible Person services
* Formula & Product Information File (PIF) Review
* CPNP Notification
* Label Review
* Product Safety Report
* Lab Testing
* Adverse Events Reporting
* UK Responsible Person services
* SCPN Notification
* US Agent services (FDA Facility & FEI Registration, Cosmetic Product Listing)
* Canadian Responsible Person services (Cosmetic Notification Forms, bilingual labelling)
* Turkish Responsible Person services (aligned with EU Cosmetics Regulation)
* Regulatory trainings for cosmetics and medical devices, available online or in-house
**Reputation / proof points**
* Specializes in market access for cosmetics, medical devices, and other industries.
* Offers compliance services globally, making them an ideal choice for manufacturers marketing in multiple global markets.
Additional information
Obelis Group provides comprehensive support for navigating complex regulatory landscapes. Their services are tailored to meet the diverse needs of businesses seeking market entry in regions such as the EU, UK, US, Canada, and Turkey. They emphasize customized training programs, adaptable to your business model and regulatory experience level, delivered through various flexible options including in-house sessions, online webinars, and dedicated learning platforms. This approach ensures your team gains the necessary knowledge and tools to confidently manage compliance requirements.
Key Highlights
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Offers EU, UK, US, Canadian, and Turkish Responsible Person services.
Source
“Our Authorized Representative and Responsible Person services provide expert guidance for swift and safe market entry, tailored to meet the diverse needs of businesses. We span regulations in the EU, UK, US, Canada and beyond to support your compliance needs effectively.”
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Provides comprehensive cosmetic compliance services including PIF review, CPNP notification, and label review.
Source
“Our Services; EU Cosmetics Responsible Person; Formula & Product Information File (PIF) Review; CPNP Notification; Label Review; Product Safety Report; Lab Testing; Recycling Symbols; Adverse Events Reporting”
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Delivers tailored regulatory training programs for cosmetics and medical devices.
Source
“Our regulatory training programs are designed to give you the knowledge and tools to confidently navigate the evolving European Union (EU) regulatory landscape. Whether you work with cosmetics, medical devices, or in-vitro diagnostics, Obelis offers tailored, professional trainings...”
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Supports market access across the EU, UK, US, Canada, and Turkey.
Source
“We span regulations in the EU, UK, US, Canada and beyond to support your compliance needs effectively.”
Certifications & Trust Signals
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Specializes in market access for cosmetics, medical devices, and other industries.
Source
“Obelis Group is your trusted partner for global regulatory compliance, specializing in market access for cosmetics, medical devices, and other industries across the EU, UK, US, Canada, and Switzerland.”
-
Offers compliance services globally, ideal for manufacturers marketing in multiple global markets.
Source
“Our international standing means we offer compliance services around the globe. This makes us an ideal choice for manufacturers who market their products in several global markets.”
Buyer Snapshot
Best for
- Manufacturers seeking EU and UK cosmetic compliance
- Companies needing to appoint a Responsible Person
- Businesses requiring product information file (PIF) preparation
- Firms needing CPNP or SCPN portal notifications
How engagement typically works
- Direct service provision
- Tailored regulatory training
Typical deliverables
- EU Responsible Person appointment
- UK Responsible Person appointment
- Product Information File (PIF) review
- CPNP Notifications
- SCPN Notifications
- Label reviews
Good to know
- Best when requiring specific regulatory expertise for EU and UK cosmetics
- Ideal for companies entering or expanding in these markets
HQ:
Brussels, Belgium
Languages:
English, French, Dutch, German
Timezones:
Europe/Brussels
Status:
listed
Services & Capabilities
EU+UK Cosmetics Compliance
Jurisdictions:
EU, UK
Countries:
BE, FR, NL, DE, ES, IT, IE, SE, DK
Industries:
Cosmetics, Personal care, Beauty
Portfolio:
1-5, 6-25, 100+
Onboarding time:
2–5 days
Pricing model:
Retainer
Starting from:
EUR 1,200
Included services:
Responsible Person role coverage, CPNP notification support, Product Information File (PIF) support, Label review (INCI and mandatory statements), Post‑market compliance and incident escalation
Supports CPNP:
Yes
Supports PIF:
Yes
Product Categories:
Cosmetics
Label Review Included:
Yes
Supports CPSR:
Yes
Supports Ukcosmetics Rp:
Yes
eudamed_onboarding_support
Additional cosmetics_rp Details
Supports CPNP
true
Supports PIF
true
Supports CPSR
true
Markets Covered
EU+UK
Can Provide Local Address On Label
true
Label Review Included
true
Onboarding Steps
The website content does not detail specific onboarding steps, required documents, timelines, or setup processes.
