Sobel Consult
Anderson Sobel Cosmetic Surgery
EU Responsible Person (RP) for cosmetics. Expert support for CPNP notifications, PIF management, label reviews, and post-market vigilance. Full Article 4 mandate and compliance coordination.
Sobel Consult serves as your fully mandated EU Responsible Person (RP) for cosmetics, handling pre-market, on-market, and post-market obligations. They provide comprehensive RP services including Article 4 mandate formalization, CPNP notifications, Product Information File (PIF) access and retention management, label and claims verification, post-market vigilance coordination, and change control across your portfolio.
Their RP workflow brings order and clarity to every regulatory obligation, helping products move into and remain on the EU market without gaps or delays. They operate as the legal gatekeeper of EU cosmetic compliance, ensuring each product remains compliant throughout its lifecycle.
About
**Who they are**
Sobel Consult specializes in navigating complex regulatory compliance landscapes, aiming to make adherence clear and achievable for businesses. They position themselves as strategic partners committed to long-term success.
**Expertise & scope**
* Expertise in regulatory compliance for cosmetics and medical devices.
* Services include Product Information File (PIF) review and preparation for EU market access.
* Support for CPNP (Cosmetic Products Notification Portal) notification and Cosmetic Product Safety Report (CPSR) preparation.
* Consultancy covers market entry strategies and optimizing regulatory workflows.
* Geographic scope includes EU and UK markets.
**Reputation / proof points**
* Focus on transforming regulations into opportunities for growth.
* Commitment to optimizing regulatory workflows and reducing compliance costs.
Sobel Consult specializes in navigating complex regulatory compliance landscapes, aiming to make adherence clear and achievable for businesses. They position themselves as strategic partners committed to long-term success.
**Expertise & scope**
* Expertise in regulatory compliance for cosmetics and medical devices.
* Services include Product Information File (PIF) review and preparation for EU market access.
* Support for CPNP (Cosmetic Products Notification Portal) notification and Cosmetic Product Safety Report (CPSR) preparation.
* Consultancy covers market entry strategies and optimizing regulatory workflows.
* Geographic scope includes EU and UK markets.
**Reputation / proof points**
* Focus on transforming regulations into opportunities for growth.
* Commitment to optimizing regulatory workflows and reducing compliance costs.
Additional information
For companies entering the EU cosmetic market, Sobel Consult emphasizes the critical nature of the Product Information File (PIF) and CPNP notification. They offer a comprehensive package to manage these processes, from documentation checks to final submission. Their approach aims to simplify the journey, ensuring products align with EU standards and avoid common pitfalls that can cause delays or rejections. By outsourcing these regulatory complexities, businesses can focus on product innovation and market growth.
Key Highlights
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Provides expert support for Cosmetic PIF review and preparation to meet EU standards.
Source
“At Sobel, we provide full support for the review and preparation of Cosmetic PIF, helping you organize critical documentation to meet EU standards.”
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Offers a complete package for EU cosmetic market entry, including CPSR preparation and CPNP notification.
Source
“Entering the European cosmetic market requires two key steps: preparing a Cosmetic Product Safety Report (CPSR) and completing the CPNP notification. At Sobel, you get both steps in one complete package.”
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Specializes in Medical Devices and Cosmetic Consultancy for markets including the United States, Canada, Brazil, and Europe.
Source
“Our Solutions Medical Devices Consultancy United States of America Canada Brazil Europe Cosmetic Consultancy United States of America Canada Brazil Europe”
Certifications & Trust Signals
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Positions themselves as strategic partners committed to regulatory compliance and long-term business success.
Source
“We’re not just consultants. We’re strategic partners committed to your regulatory compliance and long-term business success.”
Buyer Snapshot
Best for
- Cosmetic brands seeking EU market entry
- Companies needing assistance with CPNP notifications
- Businesses requiring PIF preparation and review
- Medical device and IVD companies with international regulatory needs
How engagement typically works
- Strategic partnership
- End-to-end process management
- Focus on optimizing workflows and reducing costs
Typical deliverables
- CPNP notification submission
- Completed Product Information File (PIF)
- Label review reports
- Regulatory compliance strategy
- Post-market vigilance support
Good to know
- Best when requiring specialized expertise in EU cosmetic regulations
- Suitable for companies prioritizing efficient market entry
HQ:
Lisbon, PT
Languages:
English, French, German
Timezones:
CET
Claim status:
Listed
Services & Capabilities
EUDAMED Onboarding & Data Registration Support (Mandatory Modules)
cosmetics_rp
Jurisdictions:
EU, UK
Pricing model:
Per project
Contact Category:
permanent
Contact Site:
external
Product Types:
cosmetics
Service Scope:
rp_appointment, cpnp_notification, pif_management, label_review, claims_verification, post_market_vigilance, sue_reporting, change_control, portfolio_management
Supports CPNP:
Yes
Supports PIF:
Yes
Supports CPSR:
Yes
Markets Covered:
EU, UK
Can Provide Local Address:
Yes
Label Review Included:
No
Languages:
English, French, German, Portuguese
Timezones:
CET
Service Description:
Sobel Consult provides comprehensive EU Responsible Person services for cosmetics. They handle the full RP mandate including Article 4 appointment, CPNP notifications, PIF location and retention (10-year requirement), label verification, post-market vigilance coordination, and ongoing change control. Their approach ensures products remain compliant throughout their lifecycle with a single, dependable EU address on pack.
Supports Ukcosmetics Rp:
Yes
Supports CPNP:
No
Supports PIF:
No
Supports CPSR:
No
Can Provide Local Address On Label:
Yes
Product Categories:
Face & Skin, Breast & Body, Cosmetic Surgery, Nonsurgical Treatments, Facial Rejuvenation, Breast Enhancement, Body Contouring, Non-surgical anti-aging medicine, Face Procedures, Skin Procedures, Breast Procedures, Body Procedures, Men’s Procedures
Supports Regulatory Consulting:
No
Supports Formula Compliance Checks:
No
Supports Testing Coordination Management:
No
Supports Claims Substantiation:
No
Turnaround SLA:
Custom
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