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Early Access programmes (ATU) - BlueReg Group

Early Access programmes (ATU)

BlueReg Group Specific Services for France Early Access programmes (ATU)

You can rely on the experience and expertise of our consultants for providing advice and efficient implementation of your ATU projects (nominative and cohort).

 

We can assist you in the following:

  • Provision of advice or responses to questions including strategy and/or positioning of your ATU projects
  • Preparation or review of your ATU application including the protocol for therapeutic use (PUT)
  • Submission of ATU dossiers to ANSM and follow up until ATU is granted

 

In addition, via our sister company Pharma Blue, we can manage your ATU programmes:

  • Pre-launch activities for the management of your ATU programmes: setting up a dedicated ATU team (cellule ATU), assigning toll-free phone/fax numbers and creation of a database for the management of the ATU
  • Day-to-day management of your ATU programme: Patient inclusion and follow up, validation of the pharmacist orders, processing and capturing all necessary data
  • Generation and submission of ATU periodic reports
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