EU Compliance & Regulatory Affairs

Navigate EU Cosmetic & Supplement Regulations with Total Confidence.

From CPNP notifications to GMP auditing, we handle the complex compliance landscape so you can launch faster.

Who We Serve

WetranslatecomplexEUdirectivesintoclear,actionablecomplianceroadmaps.Soyourproductsreachthemarketflawlessly.

01

Cosmetic Brands

Ensure your formulations meet EU 1223/2009 regulations without unexpected launch delays.

02

Supplement Manufacturers

Navigate EFSA requirements and novel food dossiers with scientific precision.

03

Contract Manufacturers

Maintain GMP standards and pass audits with comprehensive, audit-ready documentation.

EU Regulatory Services

Compliance, simplified. Every requirement, covered.

From CPNP notification to legal representation — each service targets a precise regulatory step. Pick the one that fits where you are.

1 - 3 Days

CPNP Fast Track

Complete EU cosmetic notification handled for you — free document check, ingredient screening, and CPNP filing by a licensed EU Responsible Person.

  • Free document check before any commitment
  • Ingredient screening against current EU Annexes and restrictions
  • CPNP portal filing handled by a licensed EU Responsible Person
Action
3 Days

CPSR Service

EU-mandatory cosmetic safety reports at a fixed €399 per formulation. Free pre-screening before you pay. Delivered in 3 days from document approval.

  • Free document pre-screening — we flag gaps before you commit
  • Part A & Part B compiled and signed by a qualified EU safety assessor
  • Compliant with Regulation (EC) No 1223/2009, Annex I
Action
4 - 8 Weeks

CE Certification (Class I MD & Class A IVD)

Full CE marking for Class I Medical Devices and Class A IVDs — technical file, Declaration of Conformity, and EC REP. Dossier review available for higher-risk classes.

  • Full certification for Class I MD & Class A IVD — technical file, DoC, and registration
  • EC REP (EU Authorized Representative) service included
Action
Immediate Setup

EU Representation & RP Services

Named EU legal representative for your product category — Responsible Person for cosmetics, EC REP for medical devices, FBO for dietary supplements.

  • Responsible Person (RP) for cosmetics — required for CPNP compliance
  • EC REP (EU Authorized Representative) for CE-marked medical devices
Action
On-Demand / Retainer

RA Consulting

Individual regulatory advice scoped to your specific situation — classification questions, compliance gaps, audit prep, or market entry strategy.

  • Product classification and regulatory framework analysis
  • Pre-market compliance review and gap assessment
Action

Not sure which service applies to your product? We'll point you in the right direction.

Get In Touch

Submit Your Compliance Inquiry

Tell us about your product and regulatory needs. Our team will get back to you within 24 hours.

Compliance Depth

Each service handles one compliance step. Precisely.

Whether you're filing your first CPNP, getting a safety report drafted, or need a legal representative in Europe — pick the service that fits your current stage. No overlap, no guesswork.

01

CPNP Fast Track

Full CPNP notification handled for you — free document review, ingredient screening, and portal filing by a licensed EU Responsible Person. In days, not months.

COSMETIC NOTIFICATION

CPNP Fast Track

ESTIMATED TIMELINE1–3 Business Days

FULL-SERVICE CPNP NOTIFICATION

We handle the complete notification process — from your raw formulation documents to a live CPNP reference number. Includes your EU Responsible Person so your product is legally covered from day one.

Key Deliverables
  • Free upfront document check — we flag what's missing before any commitment.
  • All ingredients screened against the current EU Annexes and restriction limits.
  • Your licensed EU Responsible Person files directly on the CPNP portal and issues your notification reference.

HOW IT WORKS

01
Free Document Review
02
EU Ingredient Restriction Check
03
Label & Safety Sheet Validation
04
CPNP Filing & Reference Issued

These services have dedicated pages with pricing, process details, and a free document check.

02

CPSR Service

Mandatory safety reports for EU cosmetic sales. Fixed €399 per formulation. We review your documents free before you pay — and deliver in 3 days from approval.

03

CE Certification (Class I MD & Class A IVD)

Full CE marking for Class I Medical Devices and Class A IVDs — technical file, Declaration of Conformity, and EC REP. For higher-risk classes requiring a Notified Body, we offer dossier review and support.

04

EU Representation & RP Services

Named EU representative for your product category — Responsible Person for cosmetics, EC REP for medical devices, or FBO registration for supplements.

05

RA Consulting

Bespoke regulatory advice for situations that don't fit a standard service — classification decisions, compliance gaps, audit preparation, or regulatory roadmaps.

Stay Compliant. Stay Informed.

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