Servicios
EE.UU. · Canadá · UE — Servicios de red
Punto de entrada europeo a una red de laboratorios asociados. Conformidad con la FDA de EE.UU. para exportadores europeos, conformidad con el NHPD de Health Canada, ensayos de plantas medicinales y complementos alimenticios (una especialidad poco frecuente en el continente europeo), además de NCF de la UE / ISO 22716 / cosméticos (Reglamento 1223/2009). Cada servicio se asigna al laboratorio asociado correspondiente y se entrega como un único expediente bilingüe.
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.
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