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Services France - BlueReg Group

Services France

BlueReg Group Services France

BlueReg est une société internationale proposant des conseils scientifiques et réglementaires stratégiques, ainsi que des solutions pratiques accompagnant les acteurs de l’industrie pharmaceutique.

 

Notre équipe d’experts offre un service complet de soutien ainsi que des solutions personnalisées tout au long du cycle de vie des produits, incluant le développement, la soumission, l’autorisation, la période post autorisation et le lancement.

Nos services France

Affaires réglementaires

Conseil en stratégie et analyse de la réglementation, accompagnement pour des réunions avec l’ANSM.

 

Conseil et support opérationnel :

  • Nouvelle demande d’AMM, renouvellement d’AMM
  • Variations, DMI, transferts
  • Gestion de portefeuille d’AMM
  • Accompagnement pour la mise sur le marché (demande de BlueBox, déclaration de commercialisation…)
  • Revue d’articles de conditionnements
  • Demande et gestion d’ATU et de RTU

Conformité réglementaire (Pub, DMOS, Charte)

  • Conseil et revue de documents promotionnels
  • Soumission de demande de visas publicité
  • Conseil et prise en charge de dossiers DMOS et Transparence des liens
  • Support en matière de charte de l’information promotionnelle

Affaires économiques

Conseil technique et stratégique en matière de remboursement et de prix (médicaments et DM)

 

Rédaction et coordination des dossiers pour la HAS et le CEPS (médicaments et DM) :

  • Inscription
  • Modification des conditions d’inscription
  • Renouvellement d’inscription
  • Réévaluation

Pharmacovigilance

  • Mise à disposition Responsable PV local
  • Mise en place et audit du système de PV
  • Traitement des cas
  • Rédaction de rapports de sécurité

Qualité

  • Conseil et support en matière de Management de la Qualité
  • Rédaction de Revue Qualité Produit (PQR) annuelle
  • Support et conseil pour l’obtention du statut d’Exploitant, audits, rédaction de procédures, mise à disposition de Pharmaciens Responsables Intérimaires (PRI)

L’équipe

Une équipe « France » dédiée, composée de consultants hautement qualifiés et dotés d’une expérience pratique approfondie.

 

Des experts possédant un large éventail de compétences, allant du conseil stratégique à l’exécution opérationnelle, en passant par la direction et la gestion de projets.

Atouts pour la réussite de votre projet

Une évaluation de vos besoins spécifiques et une proposition de services sur mesure.