European Experts in
USA · Health Canada · Herbal & Supplement Testing
Care Europe is the European entry point to a partner-lab network across the USA, Canada, and Europe. We deliver USA (FDA / ISO 17025) and Health Canada (NHPD) compliance for European exporters — and herbal & supplement testing, a rare expertise on the European continent that we coordinate through our US partners (Qalitex, Ayah Labs in Chicago) and selected EU labs.
🇺🇸 Qalitex (USA · ISO 17025) · 🇨🇦 Androxa (Canada · NHPD) · 🇪🇺 EU partner labs · Response within 24 h
Network Services
Six services.
Backed by labs across three continents.
Each service is delivered through the right partner lab for the job — USA (Qalitex / Ayah Labs), Canada (Androxa), or selected European labs. Care Europe coordinates the dossier, you talk to one project manager.
USA Export 🇺🇸 USA FDA Compliance for EU Exporters
Get your European product ready for the US market — FDA 21 CFR cGMP alignment, DSHEA compliance for dietary supplements, US-format CoAs, and import-readiness packages. Testing performed at our US partner Qalitex (ISO 17025, Irvine + San Diego, CA).
CA NHPD 🇨🇦 Health Canada NHPD Compliance
NPN application support, NHPD dossier preparation, DIN submissions, and Canadian GMP gap assessments for European brands entering the Canadian market. Powered by our Canadian partner Androxa (testing-lab.ca).
Herbal / Supp 🌿 Herbal & Supplement Testing — Rare EU Expertise
Botanical identity (HPTLC, DNA barcoding), adulteration screening, heavy metals (ICP-MS, USP <232>/<233>), microbiology, and stability — a rare combined expertise on the European continent. Coordinated with our US specialist Ayah Labs (Chicago) and selected European labs.
Drug Dev 🧬 Drug Development Consulting
End-to-end advisory from pre-clinical through clinical to dossier submission. Chemical, herbal/botanical, biological, and OTC medicinal products targeting EU marketing authorisation, FDA NDA/ANDA, or Health Canada 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 European facility for inspections and US / Canadian export certification.
Cosmetics ✨ Cosmetic Compliance EU 1223/2009
Full EU Regulation 1223/2009 compliance — CPSR (Cosmetic Product Safety Report), CPNP notification, Responsible Person designation, ISO 22716 GMP — plus US (MoCRA) and Canadian Cosmetic Notification Form (CNF) export documentation.
Our Network
One European entry point.
Three continents of lab capacity.
European brands and manufacturers tell us what they need. We route the work to the right partner lab — by accreditation scope, by jurisdiction, by speciality — and deliver back as one coordinated dossier.
USA Partner
Qalitex Laboratories 🇺🇸
ISO/IEC 17025 accredited lab in Irvine + San Diego, California. Powers our USA FDA compliance offer (CoAs, MoCRA, DSHEA, cGMP). Plus a Chicago herbal/supplement satellite — Ayah Labs — for botanical identity work.
qalitex.com →Canada Partner
Androxa 🇨🇦
Canadian Health Canada NHPD specialist. Powers our Canada export offer — NPN applications, NHPD dossiers, DIN submissions, Canadian GMP gap assessments.
testing-lab.ca →EU Entry Point
Care Europe 🇪🇺
France-registered. We coordinate the dossier, route the right tests to the right partner lab, and deliver back to you in EN/FR. We also work with selected European labs for tests where local processing is required.
You are hereAll partner labs operate under their own ISO/accreditation scopes. Care Europe coordinates and never claims accreditation that belongs to its partners.
Process
A straightforward process,
from first contact to delivery
Independent expertise. Clear deliverables. Defined timelines.
Tell us your product + target market
Share your product, formulation, regulatory status, and where you need to land it — USA, Canada, EU, or all three. We identify the right partner lab(s).
We coordinate the partner-lab network
Care Europe routes each test to the right lab — Qalitex (USA / ISO 17025), Androxa (Canada / NHPD), Ayah Labs (USA / herbal), or selected EU partners. One project manager, one dossier, no juggling.
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.
A Real Cross-Continental Network
Care Europe is not a single France-based shop. We are the European entry point to a coordinated partner-lab network: Qalitex (USA, ISO 17025), Androxa (Canada, NHPD), Ayah Labs (USA, herbal/supplement specialist), plus selected European labs.
USA FDA Specialists for European Brands
We know exactly what FDA and US buyers require from European suppliers — cGMP documentation, US-format CoAs, DSHEA-compliant labels, MoCRA cosmetic substantiation. Testing routed to Qalitex (Irvine + San Diego, CA).
Health Canada NHPD Specialists
NPN application support, Health Canada NHPD-compliant dossiers, and Canadian GMP gap analyses for European brands entering the Canadian market. Powered by our Canadian partner Androxa.
Rare Herbal & Supplement Expertise
Botanical identity (HPTLC, DNA barcoding), adulteration screening, traditional herbal medicinal products (THMP), HMPC monographs — combined depth that is hard to source from a single European lab. We pull from our US partners + EU specialists.
One Project Manager, Whole Network
You talk to Care Europe. We coordinate the right partner lab for each test, assemble the dossier, and deliver in EN/FR. No juggling three labs or chasing CoAs across time zones.
Fast, Defined Turnarounds
Regulatory strategy assessments in 1–2 weeks. GMP gap analyses in 2–4 weeks. Export dossiers in 4–8 weeks. Lab analytical turnarounds depend on the partner-lab queue but typically 5–14 days.
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