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Ce service est plus particulièrement destiné aux startups ou aux entreprises qui n’ont pas encore commercialisé de produit sur le marché européen. En général, elles ne possèdent pas de ressource réglementaire dans les pays concernés. Ce service s’adresse également aux entreprises de taille moyenne qui ne sont pas encore présentes dans les pays de l’UE. Il peut être mis en œuvre tout au long du processus d’enregistrement, jusqu’au lancement et à la mise sur le marché du produit dès que celui-ci a obtenu l’autorisation adéquate.
Nous vous guidons à travers les exigences de chaque pays, qu’il s’agisse de stratégie réglementaire locale, soumission post-autorisation, préparation du lancement de produits, révision de documents promotionnels, conformité des soins de santé, pharmacovigilance, qualité, chaîne logistique, révision d’étiquetage, fixation des prix et remboursement.
Nous avons un réseau mondial de partenaires hautement qualifiés et dotés d’une solide expérience dans leur domaine et sur leur marché. Vous n’aurez qu’un seul contrat, un seul point de contact et une seule facture, pour un suivi rapproché et homogène. À partir de l’analyse de vos besoins, nous coordonnons la collecte des informations ou la prestation de services avec l’ensemble de nos partenaires.
