EU Regulatory Consulting
From Development to Export
Care Europe provides independent regulatory consulting for European manufacturers across drug development, GMP compliance, food supplements, parapharmaceuticals, herbal products, and cosmetics — with dedicated expertise in FDA and Health Canada export requirements.
Response within 24 hours · No obligation · EN/FR
Regulatory Services
Six independent services.
Each one a speciality.
Strategy 📋 Regulatory Strategy & Product Classification
Determine the correct regulatory status for your product — medicinal, parapharmaceutical, food supplement, herbal, or cosmetic — across EU, FDA, and Health Canada frameworks. Avoid costly misclassification before entering any market.
Drug Dev 🧬 Drug Development Consulting
End-to-end advisory from pre-clinical development through clinical phases to dossier submission. We support chemical, herbal/botanical, biological, and OTC medicinal products seeking EU marketing authorisation or North American approval.
GMP / ISO 🏭 GMP & Quality Systems
Gap analysis, audit readiness, and quality system implementation aligned with ISO 22716, EU GMP, and ISO 17025. Prepare your facility and documentation for regulatory inspections and export certifications.
Testing 🔬 Lab Analysis — Supplements & Parapharmaceuticals
GMP-compliant analytical testing and CoA preparation for food supplements, nutraceuticals, parapharmaceuticals, and herbal products. Reports formatted in French and English for EU, FDA, and Health Canada submissions.
Cosmetics ✨ Cosmetic Compliance & Safety
Full EU Regulation 1223/2009 compliance including CPSR (Cosmetic Product Safety Report), CPNP notification, Responsible Person designation, ISO 22716 GMP, and export documentation for US and Canadian markets.
Export 🌎 North America Export & Market Entry
FDA 21 CFR cGMP alignment, DSHEA compliance for dietary supplements, Health Canada NHP/NHPD dossiers, and full import readiness packages for European manufacturers targeting the US and Canadian markets.
Process
A straightforward process,
from first contact to delivery
Independent expertise. Clear deliverables. Defined timelines.
Tell us about your product
Share your product type, formulation, regulatory status, and target markets. We assess your situation and identify the right service for your needs.
We build your regulatory roadmap
Our consultants define your compliance pathway — whether that is a GMP audit, dossier preparation, product classification, or a full drug development strategy.
You receive actionable deliverables
Gap analyses, regulatory reports, export dossiers, or submission-ready files — delivered in French and English within agreed timelines.
Why Care Europe
What sets us apart from other EU consultants
Brands choose Care Europe for deep EU expertise, bilingual French-language support, and a proven track record with FDA and Health Canada compliance.
Full-Spectrum Regulatory Expertise
From product classification and drug development to GMP audits and export dossiers — we cover the complete regulatory lifecycle across pharmaceuticals, supplements, herbal products, parapharmaceuticals, and cosmetics.
Drug Development to Submission
We support companies through the entire development chain: pre-clinical strategy, clinical advisory, dossier compilation, and submission to EU, FDA, or Health Canada authorities.
FDA & Health Canada Specialists
We know exactly what US and Canadian regulators and buyers require from European suppliers — cGMP documentation, US-format CoAs, DSHEA-compliant labels, and NHPD-compliant dossiers.
Bilingual EN/FR Support
All regulatory reports, export dossiers, and compliance documents prepared in French and English — essential for European labs working with North American regulatory authorities.
ISO 17025 Lab Network
Direct access to ISO 17025 accredited laboratory testing through the Qalitex Group (USA) and Androxa (Canada) — a seamless EU-to-North America analytical solution.
Fast, Defined Turnarounds
Regulatory strategy assessments in 1–2 weeks. GMP gap analyses in 2–4 weeks. Export dossiers in 4–8 weeks. We work to your timeline.
Product Categories
We consult across all health product types
Whether your product is a pharmaceutical, a parapharmaceutical, a herbal remedy, a nutraceutical, or a cosmetic — Care Europe provides the right regulatory pathway for it.
💊 Food Supplements & Nutraceuticals
EU Directive 2002/46/EC, FDA DSHEA, Health Canada NHP — formulation review, CoA, labeling
🌿 Herbal & Botanical Products
Traditional Herbal Medicinal Products (THMP), HMPC monographs, EU registration, and export
🧴 Parapharmaceuticals
Borderline product classification, pharmacy-channel compliance, EU and North American market positioning
✨ Cosmetics & Dermo-Cosmetics
CPSR, CPNP, Responsible Person, ISO 22716, FDA & Health Canada export documentation
🧬 OTC & Medicinal Products
Marketing authorisation strategy, pre-clinical to clinical dossier, EU/FDA/Health Canada submissions
🏭 Contract Labs & Manufacturers
ISO 17025 documentation, bilingual analytical reports, GMP audit support
Care Europe at a Glance
Client Results
What our clients say
Independent consulting built on results. Here is what brands say after working with Care Europe.
"Care Europe gave us a complete regulatory roadmap for entering the French market with our nutraceutical line. Their bilingual support was invaluable — they prepared our dossiers in both French and English, and we cleared customs without a single issue."
Marc D.
Director of Operations · North American supplement brand
"We needed to reclassify a borderline product before submitting to ANSM. Nour's team identified the issue immediately and provided a clear compliance pathway. What could have taken months was resolved in three weeks."
Sophie L.
Regulatory Affairs Manager · EU cosmetics manufacturer
"Our GMP audit was scheduled in 6 weeks and we had no documentation system in place. Care Europe performed a gap analysis and helped us implement a compliant quality system in time. The inspector found no critical issues."
Ahmed K.
Quality Manager · Contract laboratory, France
Common Questions
Frequently asked questions
How quickly can you start working on our project?
We typically respond within 24 hours and can begin a regulatory assessment within 3–5 business days. For urgent timelines, contact us directly and we will prioritise accordingly.
Do you work with brands outside the EU?
Yes. A large part of our work is helping North American (US and Canadian) brands enter EU markets, and European manufacturers seeking FDA or Health Canada approval for their products.
What does a Free Regulatory Assessment include?
A 30-minute consultation where we review your product type, current regulatory status, and target markets. We identify the key compliance gaps and recommend the most direct path forward — at no cost to you.
Do you only work with pharmaceutical companies?
No. We work across the full health product spectrum: pharmaceuticals, food supplements, nutraceuticals, herbal products, parapharmaceuticals, cosmetics, and dermo-cosmetics.
Nour Abochama
Quality & Regulatory Advisor, Care Europe
VP Operations, Qalitex
Chemical engineer with 17+ years in laboratory operations, quality assurance, and regulatory compliance across Europe and North America. Expert in GMP, ISO 17025, EU cosmetics, supplement directives, and FDA/Health Canada export.
Proven Expertise
Hear Nour talk about supplements,
cosmetics & regulatory science
Nour hosts Nourify & Beautify — a podcast and YouTube channel on supplement safety, beauty science, and ingredient transparency, with 46,700+ subscribers and 321,000+ views.
Book your free regulatory assessment
Tell us about your product and your regulatory challenge. We respond within 24 hours with an honest assessment and a clear next step — no obligation, no cost.
EN/FR · France Registered · Response in 24h