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Regulatory affairs

Iris Pharma provides regulatory services in support of global clinical trials and clinical development plans. We conduct clinical trials on medicinal products in compliance with current French, European and International guidelines.

  • E-submission using the EudraCT database of all clinical trials commencing in the European Community
  • Notification to Regulatory Authorities of amendments
  • Assistance with drug supply and labeling
  • Iris Pharma’ staffs are trained in clinical trial management according to the European directive (2001/20/CE) to ensure full compliance with all applicable requirements
  • Declaration of expeditable Serious Adverse Events (SAEs) to the Regulatory Authorities in France and Europe in accordance with the European directive (2001/20/CE). All declarations in France are performed according to the pilot phase of the French competent authority - the Agence Nationale de Sécurité du Médicament et des produits de santé, ANSM (formerly known as Agence Française de Sécurité Sanitaire des Produits de Santé, AFSSAPS) - on the CIOMS-I declaration form.