Obelis Group
★★★★★
4.2
/ 5
•
21 reviews
Obelis Group is a trusted regulatory partner, supporting market access for medical devices, cosmetics, food supplements, and other sectors across the EU, UK, US, Switzerland, Canada, and Türkiye.
Obelis Group is a leading regulatory compliance specialist, dedicated to accelerating your market access worldwide. With extensive experience in the EU, UK, US, and Switzerland, Obelis provides expert guidance and comprehensive services for a wide range of industries, including Medical Devices, Cosmetics, Toys, Food Supplements, and Motor Vehicles. We act as your Authorised Representative and Responsible Person, ensuring your products meet all local regulatory requirements. Our services encompass formula review, labelling compliance, claims verification, product registration, technical documentation management, and communication with regulatory authorities. Whether you are navigating the complexities of the EU General Product Safety Regulation (GPSR) or ensuring your toys meet stringent safety standards, Obelis offers tailored solutions. Obelis also provides specialized training programs to help your team master EU compliance requirements for cosmetics and medical devices. Our flexible training options, including in-house, online, and on-demand modules, empower your staff with the knowledge and tools needed for successful market entry and sustained compliance. Partner with Obelis to confidently bring your products to international markets while mitigating risks and building consumer trust.
About
Obelis specializes in ensuring regulatory compliance for Medical Devices, Cosmetics, and other industries. Through its Authorized Representative and Responsible Person services, the company provides expert guidance to facilitate swift and safe market entry, offering solutions tailored to the diverse needs of businesses. Obelis supports compliance across regulatory frameworks in the EU, UK, US, Switzerland, Canada, Türkiye, helping organizations meet their regulatory obligations effectively.
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 Türkiye. 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
- Offers EU, UK, US, Canadian, and Turkish Responsible Person services.
- Provides comprehensive cosmetic compliance services including PIF review, CPNP notification, and label review.
- Delivers tailored regulatory training programs for cosmetics and medical devices.
- Supports market access across the EU, UK, US, Canada, and Turkey.
Certifications & Trust Signals
- Specializes in market access for cosmetics, medical devices, and other industries.
- Offers compliance services globally, ideal for manufacturers marketing in multiple global markets.
Buyer Snapshot
Best for
- Manufacturers seeking market access in the EU, UK, US, Canada, and other global markets
- Companies needing to appoint a Responsible Person or Agent
- Businesses requiring regulatory training for compliance teams
How engagement typically works
- Partnership for global regulatory compliance
- Tailored training programs
- End-to-end market access support
Typical deliverables
- EU Responsible Person services
- UK Responsible Person services
- US Agent services
- CPNP Notification
- SCPN Notification
- Product Information File (PIF) Review
Good to know
- Best when targeting multiple global markets including the EU, UK, US, Canada, Türkiye, and other major international markets
- Best when requiring specialized regulatory expertise for cosmetics and medical devices
HQ:
Brussels, Belgium
Languages:
English, French, Dutch, German, Italian
Timezones:
Europe/Brussels, Europe/Zurich, America/New_York, CET
Claim status:
Claimed
Services & Capabilities
EU+UK Cosmetics Compliance
Jurisdictions:
EU, UK, CH, US, OTHER
Countries:
BE, FR, NL, DE, ES, IT, IE, SE, DK, United States, United Kingdom, Canada, Switzerland
Industries:
Cosmetics, Personal care, Beauty, Medical Devices, IVD, Consumer Goods
Portfolio:
1-5, 6-25, 100+, 26-100
Response SLA:
24 hours
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, IVD, Class I, Class IIa, Class III, Class IIb
Label Review Included:
Yes
Supports CPSR:
Yes
Supports Regulatory Consulting:
Yes
Supports Formula Compliance Checks:
Yes
Supports Testing Coordination Management:
Yes
Supports Claims Substantiation:
No
Supports Ukcosmetics Rp:
Yes
Can Provide Local Address On Label:
No
eudamed_onboarding_support
Jurisdictions:
EU
Industries:
Medical Devices, IVD
Modules Supported:
Actor/SRN, Market Surveillance, UDI/Devices, Certificates
Submission Approach:
Portal
Managed Service Available:
No
gpsr_rep
Jurisdictions:
EU
Coverage:
EU
Product Categories Supported:
consumer_electronics, toys_children, personal_care, furniture, other, beauty_cosmetics
Provides Euaddress On Label:
No
Supports Risk Assessment:
Yes
Supports Technical Documentation:
Yes
Supports Incident Reporting:
Yes
Supports Recall Management:
No
Traceability Support:
No
eu_ar
Jurisdictions:
EU
Countries:
BE, NL, DE, FR, IE, ES, IT
Industries:
Medical devices, IVD, Healthcare
Portfolio:
26-100, 100+
Response SLA:
48 hours
Onboarding time:
3–21 days
Pricing model:
Retainer
Starting from:
EUR 4,000
Included services:
EU Authorized Representative (EC REP) designation, Authority liaison and document availability support, Vigilance escalation and FSCA coordination, Labeling/EC REP identification review, Post-market support workflows (complaints, vigilance escalation)
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
IVD, Class I, Class IIb, Class Is/Im/Ir, Class III, Class IIa
Post Market Support:
Yes
Labeling Review:
Yes
EU Entity Country:
Belgium
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
ch_rep
Jurisdictions:
CH
Countries:
CH
Industries:
Medical devices, IVD
Portfolio:
100+
Response SLA:
24 hours
Onboarding time:
1–5 days
Pricing model:
Retainer
Starting from:
CHF 3,500
Included services:
Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Device Classes Supported:
Class I, IVD, Class III, Class IIa, Class IIb
Swiss Local Contact:
Yes
Labeling Support:
Yes
Swiss Entity Canton Or Region:
Baar / ZG (Canton of Zug)
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
us_agent_fda
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, IVDs
Portfolio:
6-25, 26-100, 100+
Response SLA:
24 hours
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
Product Type:
devices, cosmetics, food
Annual Renewal Support:
No
Registration Support:
Yes
Recall Support:
No
Inspection Support:
Yes
Emergency Contact24x7:
No
Annual Renewal Reminder:
No
gdpr_art27_rep
Jurisdictions:
EU, UK
Coverage:
EU, UK
Supports Special Category Data:
No
Supports Children Data:
No
Supports Biometric Data:
No
Supports Health Data:
No
Dpa Available:
No
Subprocessor List Available:
No
uk_rp
Jurisdictions:
UK
Response SLA:
hours
Supports GB:
No
Supports NI:
No
MHRA Support:
No
Can Be Named On Label:
No
MHRA Portal Support:
No
Vigilance Support:
No
Additional cosmetics_rp Details
Supports CPNP
Yes
Supports PIF
Yes
Supports CPSR
Yes
Markets Covered
EU, UK
Can Provide Local Address On Label
No
Label Review Included
Yes
Onboarding Steps
The website content does not detail specific onboarding steps, required documents, timelines, or setup processes.
Supports Regulatory Consulting
Yes
Supports Formula Compliance Checks
Yes
Supports Testing Coordination Management
No
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