Services
USA · Canada · UE — Services du réseau
Point d'entrée européen vers un réseau de laboratoires partenaires. Conformité aux exigences de la FDA pour les exportateurs européens, conformité aux exigences de Santé Canada (NHPD), analyses de plantes et compléments alimentaires (une expertise rare sur le continent européen), ainsi que BPF UE / NF EN ISO 22716 / cosmétiques au titre du Règlement (CE) n° 1223/2009. Chaque service est orienté vers le laboratoire partenaire approprié et livré sous la forme d'un dossier bilingue unique.
EU Regulatory Consulting
Navigate REACH, EU Cosmetics Regulation 1223/2009, and EU food supplement directives with an experienced France-based regulatory team.
French Lab Analysis
GMP-compliant analytical testing and CoA preparation in French and English — for EU, FDA, and Health Canada regulatory submissions.
European Market Entry
Complete regulatory pathway consulting for North American supplement and cosmetic brands entering EU markets — from gap analysis to first sale.
Cosmetic Compliance EU
Complete compliance service for EU Cosmetics Regulation — CPSR, CPNP notification, Responsible Person designation, and ISO 22716 GMP from an experienced EU regulatory team.
Food Supplement EU Compliance
Navigate EU Food Supplements Directive 2002/46/EC — notification procedures, ingredient compliance, and labeling requirements for EU market entry.
Regulatory Strategy & Product Classification
Determine the correct regulatory status for your product — across EU, FDA, and Health Canada frameworks — before you invest in compliance.
Drug Development Consulting
Independent regulatory advisory for the full drug development lifecycle — from early-stage strategy through clinical phases to EU marketing authorisation or North American approval.
GMP & Quality Systems
Gap analysis, audit readiness, and quality system implementation for European manufacturers preparing for regulatory inspections and export certifications.
Besoin d'une solution réglementaire sur mesure ?
Nous proposons des prestations de conseil réglementaire UE sur mesure, au-delà des services référencés. Contactez-nous pour examiner vos besoins spécifiques.
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