CE.way Regulatory Consultants Ltd.
★★★★★
5.0
/ 5
•
30 reviews
CE.way offers comprehensive regulatory and testing solutions for cosmetic products, ensuring market access in the EU and UK. They provide expert guidance on compliance, safety assessments, and product testing.
CE.way Regulatory Consultants Ltd. specializes in helping businesses bring cosmetic products to market efficiently, with a strong focus on EU and UK regulations. They offer a full suite of services including regulatory consulting, product information file (PIF) preparation and review, CPNP/SCPN notifications, and acting as the EU and/or UK Responsible Person (RP). Their testing capabilities are extensive, covering crucial areas like stability and compatibility testing, preservative efficacy testing (challenge tests), and comprehensive microbiology testing to ensure product safety and compliance with standards such as ISO 29621 and ISO 11930. CE.way also provides expert cosmetics safety assessments (CPSR), a mandatory requirement for placing products on the EU/UK market. They meticulously evaluate product formulas, raw material safety, packaging compatibility, and microbiological data to guarantee consumer safety. With their in-house lab facilities and deep regulatory knowledge, CE.way acts as a trusted partner for navigating the complexities of cosmetic product compliance.
About
**Who they are**
CE.way Regulatory Consultants Ltd. provides comprehensive regulatory and testing solutions to ensure cosmetic products can access the EU and UK markets. They offer expert guidance on compliance, safety assessments, and product testing.
**Expertise & scope**
* **EU & UK Cosmetics Regulations:** Assistance with fulfilling all regulatory requirements for placing products on the EU and UK markets.
* **Product Information File (PIF) Preparation & Review:** Services to create and review essential documentation.
* **Cosmetic Product Safety Assessment (CPSR):** Conducting safety assessments as required by EU Regulation 1223/2009 and UK regulations.
* **Stability & Compatibility Testing:** Evaluating product stability under various conditions to determine shelf life and period after opening, as mandated by regulations.
* **Preservative Efficacy Testing (PET) / Challenge Testing:** Assessing the effectiveness of preservative systems against microbial contamination, following ISO 11930:2019 or USP 51 standards.
* **Microbiological Testing:** Testing for key microbiological specifications to ensure product safety and compliance with EU regulations, including Total aerobic plate count (ISO 21149:2017), Yeast & mould count (ISO 16212:2017), and specific pathogen testing (e.g., Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, Escherichia coli).
* **Safety Data Sheet (SDS) Preparation:** Creating SDS documents for hazardous substances or mixtures classified under Regulation (EC) No 1272/2008.
* **Patch Testing:** Recommending and facilitating patch tests to determine potential skin irritation, providing further proof of product safety.
**Reputation / proof points**
* Adherence to international standards such as ISO 29621, ISO 11930:2019, ISO 21149:2017, ISO 16212:2017, ISO 22718:2016, ISO 22717:2016, ISO 18416:2015, ISO 21150:2015.
* Expertise in EU Cosmetics Regulation 1223/2009 and UK Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019.
CE.way Regulatory Consultants Ltd. provides comprehensive regulatory and testing solutions to ensure cosmetic products can access the EU and UK markets. They offer expert guidance on compliance, safety assessments, and product testing.
**Expertise & scope**
* **EU & UK Cosmetics Regulations:** Assistance with fulfilling all regulatory requirements for placing products on the EU and UK markets.
* **Product Information File (PIF) Preparation & Review:** Services to create and review essential documentation.
* **Cosmetic Product Safety Assessment (CPSR):** Conducting safety assessments as required by EU Regulation 1223/2009 and UK regulations.
* **Stability & Compatibility Testing:** Evaluating product stability under various conditions to determine shelf life and period after opening, as mandated by regulations.
* **Preservative Efficacy Testing (PET) / Challenge Testing:** Assessing the effectiveness of preservative systems against microbial contamination, following ISO 11930:2019 or USP 51 standards.
* **Microbiological Testing:** Testing for key microbiological specifications to ensure product safety and compliance with EU regulations, including Total aerobic plate count (ISO 21149:2017), Yeast & mould count (ISO 16212:2017), and specific pathogen testing (e.g., Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, Escherichia coli).
* **Safety Data Sheet (SDS) Preparation:** Creating SDS documents for hazardous substances or mixtures classified under Regulation (EC) No 1272/2008.
* **Patch Testing:** Recommending and facilitating patch tests to determine potential skin irritation, providing further proof of product safety.
**Reputation / proof points**
* Adherence to international standards such as ISO 29621, ISO 11930:2019, ISO 21149:2017, ISO 16212:2017, ISO 22718:2016, ISO 22717:2016, ISO 18416:2015, ISO 21150:2015.
* Expertise in EU Cosmetics Regulation 1223/2009 and UK Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019.
Additional information
CE.way offers flexible service packages, allowing clients to order individual services or choose comprehensive packages tailored to their needs. They emphasize that services like the responsible person service are distinct from other offerings. For specific pricing and package details, clients are encouraged to contact CE.way directly for a personalized offer. Their services are designed to streamline the process of bringing cosmetic products to the EU and UK markets, ensuring all necessary safety and regulatory documentation, such as the Product Information File (PIF) and Cosmetic Product Safety Report (CPSR), are meticulously prepared and reviewed.
Key Highlights
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Provides comprehensive regulatory and testing solutions for EU and UK cosmetic market access.
Source
“CE.way cosmetics regulatory services that help you fulfil all of the regulatory requirements posed by the EU and UK cosmetics regulations and consequently enable you to place your products on the EU and UK market.”
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Expertise in Product Information File (PIF) preparation and review.
Source
“Product information file (PIF) preparation”
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Conducts essential safety testing including stability, compatibility, and challenge tests.
Source
“The cosmetic product stability and compatibility test is required by EU Cosmetics Regulation 1223/2009 and the UK Schedule 34...”
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Performs microbiological testing according to international standards (e.g., ISO 21149:2017).
Source
“Total aerobic plate count (ISO 21149:2017)”
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Offers Cosmetic Product Safety Assessment (CPSR) services.
Source
“Cosmetics safety assessment (CPSR)”
Certifications & Trust Signals
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Adheres to EU Cosmetics Regulation 1223/2009 and UK Schedule 34.
Source
“The cosmetic product stability and compatibility test is required by EU Cosmetics Regulation 1223/2009 and the UK Schedule 34...”
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Utilizes international standards for testing, including ISO and USP.
Source
“Total aerobic plate count (ISO 21149:2017)”
Buyer Snapshot
Best for
- Cosmetic brands seeking EU and UK market access
- Manufacturers requiring regulatory compliance support
- Companies needing safety assessments and testing coordination
How engagement typically works
- Project-based service delivery
- Customizable service packages
- Direct consultation for offers
Typical deliverables
- Product Information File (PIF)
- Cosmetic Product Safety Report (CPSR)
- Stability test reports
- Microbiological test reports
- Safety Data Sheets (SDS)
Good to know
- Best when requiring specialized EU and UK cosmetics regulatory expertise.
- Engagement requires direct contact for service packages and pricing.
Pricing
Model:
Custom pricing
HQ:
United States, EU
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
EU+UK Cosmetics Compliance
Jurisdictions:
EU, UK
Countries:
EU, UK
Industries:
Medical Devices, Pharmaceuticals, Biotech
Onboarding time:
7–21 days
Pricing model:
Custom pricing
Supports CPNP:
No
Supports PIF:
No
Product Categories:
Oral care, Make-up and Decorative Cosmetics
Label Review Included:
Yes
Supports CPSR:
Yes
Supports Claims Substantiation:
Yes
Supports Ukcosmetics Rp:
Yes
Can Provide Local Address On Label:
No
Turnaround SLA:
Custom
Supports Regulatory Consulting:
Yes
Supports Formula Compliance Checks:
Yes
Additional cosmetics_rp Details
Supports CPNP
false
Supports PIF
true
Supports CPSR
true
Markets Covered
EU, UK
Can Provide Local Address On Label
false
Label Review Included
false
Onboarding Steps
Contact CE.way for an offer and to choose service packages.
Supports Regulatory Consulting
true
Supports Formula Compliance Checks
true
Supports Testing Coordination Management
true
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