Dienstleistungen
USA · Kanada · EU — Netzwerkdienstleistungen
Europäischer Zugangspunkt zu einem Partnerlabor-Netzwerk. FDA-Konformität für europäische Exporteure, Health-Canada-NHPD-Konformität, Prüfung von pflanzlichen Arzneimitteln und Nahrungsergänzungsmitteln (eine in Europa selten verfügbare Expertise) sowie EU-GMP / DIN EN ISO 22716 / Verordnung (EG) Nr. 1223/2009 für kosmetische Mittel. Jede Dienstleistung wird an das geeignete Partnerlaboratorium weitergeleitet und als einheitliches zweisprachiges Dossier übergeben.
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.
Individuelle regulatorische Lösung gesucht?
Wir bieten individuelle EU-Regulierungsberatung, die über diese Liste hinausgeht. Nehmen Sie Kontakt auf, um Ihre spezifischen Anforderungen zu besprechen.
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