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.
WetranslatecomplexEUdirectivesintoclear,actionablecomplianceroadmaps.Soyourproductsreachthemarketflawlessly.
Cosmetic Brands
Ensure your formulations meet EU 1223/2009 regulations without unexpected launch delays.
Supplement Manufacturers
Navigate EFSA requirements and novel food dossiers with scientific precision.
Contract Manufacturers
Maintain GMP standards and pass audits with comprehensive, audit-ready documentation.
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.
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
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
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
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
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
Not sure which service applies to your product? We'll point you in the right direction.
Submit Your Compliance Inquiry
Tell us about your product and regulatory needs. Our team will get back to you within 24 hours.
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.
CPNP Fast Track
Full CPNP notification handled for you — free document review, ingredient screening, and portal filing by a licensed EU Responsible Person. Days, not months.
CPNP Fast Track
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.
- 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
These services have dedicated pages with pricing, process details, and a free document check.
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.
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.
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.
RA Consulting
Bespoke regulatory advice for situations that don't fit a standard service — classification decisions, compliance gaps, audit preparation, or regulatory roadmaps.
CPNP Fast Track
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.
- 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
These services have dedicated pages with pricing, process details, and a free document check.
Stay Compliant. Stay Informed.
Receive critical updates on EU regulation shifts, compliance deadlines, and market access changes directly to your inbox.
How does AMVE approach regulatory consulting?
AMVE provides practical regulatory and market-entry support for cosmetics, medical skincare, aesthetic medicine, and MedTech-adjacent companies preparing for Europe. The consulting work focuses on coordination, readiness, gap identification, claims discipline, documentation structure, and alignment between compliance work and commercial entry.
Regulatory support tied to market entry
AMVE helps teams understand what needs to be prepared before a product or concept is presented to European partners, clinics, distributors, or buyers. This can include cosmetic compliance topics, responsible person coordination, CPSR and CPNP dependencies, MDR readiness discussions, and documentation review.
Claims, labels, and product information
Claims and labels are not isolated copy decisions. They need to fit the product category, available support, intended use, and compliance workflow. AMVE helps make these decisions visible before they become launch risks.
Bounded role and responsibility
AMVE supports preparation, coordination, and commercial translation. It does not act as a regulator, notified body, legal authority, or guarantee provider for approvals or market results.
What does AMVE regulatory consulting cover?
AMVE regulatory consulting can cover readiness checks, document organization, CPNP and CPSR coordination, claims and label review, responsible person coordination, MDR or CE positioning discussions, and market-entry planning.
Is AMVE a regulator or notified body?
No. AMVE is not a regulator, notified body, or certification authority. It supports preparation, coordination, and commercial translation for companies entering or growing in Europe.
Why combine regulatory and commercial consulting?
Combining the work helps prevent a product from being commercially promoted before its documents, claims, labels, and partner requirements are clear enough for European buyers to evaluate.
What makes a good first regulatory inquiry to AMVE?
A good inquiry includes product category, intended use, target market, current documents, labels, claims, responsible person status, and the commercial goal for Europe.