An effective 360° pre-launch support

Client need and context:

Our client was a French biotech developing its first drug in a neurological rare disease. The drug was granted an orphan drug designation a year before we met. Their international headquarters are located in France. When they first came to BlueDil int’l, their pivotal Phase III study was ongoing. They wanted to open European subsidiaries, in Germany, Spain, Italy and in the UK, to start prelaunch activities.

BlueDil int’l approach:

In the first place, BlueDil int’l conducted an early access program assessment with a specific focus on the disease at stake and their product. Each company of the big 5 presented their local early access system. They made an assessment and scheduled a timeline for a potential early access program (or compassionate use) in our client’s orphan indication.

Following this first step, BlueDil int’l proposed a more cost-effective way to meet their needs. Considering the size of the market and the future indication of their product, opening affiliates would have been very costly while a few days per month per country to start the activities was the appropriate level of resources needed for prelaunch activities.


Since 2017, BlueDil int’l has been working with this client in France, UK, Germany, Spain and Italy on:

  • o Local market access activities:
    • – Early access program assessment and implementation
    • – Regulatory support and meeting with the authorities
    • – PIM status in the UK
    • – Several nominative ATU request from French physicians


  • o Local Medico-marketing activities:
    • – Map 177 centers, of which93 were visited
    • – Built relationship with 7 patient advocacy groups
    • – Support in the selection of centers for their pediatric pivotal study
    • – Better understand of disease management through interviewing more than 145 physicians
    • – Support QoL observational study and patient pathway communication
    • – Write technical documents in 5 different languages
    • – Participate in 20 local congresses for disease awareness
    • – Gather 1 or 2 advisory board in each of the big 5


To coordinate these activities, BlueDil int’l appointed a Project Director who put in place all needed processes such as:

  • o Global CRM
  • o Monthly reports
  • o Monthly teleconferences: global and country specific


Benefits for you

    • o An approach cost-effectiveness: savings 2,6M€/year
      • – Only invest needed time
      • – Budget control adapting the number of days worked by the consultants according to our client’s needs
    • o A high flexible attitude:
      • – No internal employees to hire and manage, substitution of Affiliates before Marketing Authorization to prepare the market locally
      • – Dedicated team bringing speed and momentum
    • o A time and coordination effectiveness process:
      • – Plug and play: mission started within a month
      • – One centralized point of contact to gather local information
      • – Monthly updates for the client and the countries