French Early Access Program management for a US pharmaceutical company

March 30, 2022
  • Early Access to market

An American pharmaceutical company starting to build its European affiliates entrusted PharmaBlue with the responsibility of submitting, obtaining, and implementing a French Early Access Program for its orphan drug.

PharmaBlue support them for the whole process of submission (advice, writing activities and support for meeting with the Competent Authorities) as well as for the early access operational management through to Marketing Authorization.

PharmaBlue (a BlueReg company) as French “exploitant” company can provide operational, pharmacovigilance and regulatory support in the management of early access programs in France.

Indeed, PharmaBlue partners with a lot of US companies looking to outsource early access programs in France and Exploitant responsibilities in the field of rare or serious disease & unmet medical need.

Register to download the Case study

    By sending this form, I agree that my personal data will be saved and processed according to data protection regulations and will be used only for commercial and marketing purposes only.

    Learn more

    BlueReg undertakes to comply with the regulations in force applicable to the processing of personal data and, in particular, Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 applicable as from 25 May 2018 (hereinafter, "the General Data Protection Regulations" or GPDR) and the national laws resulting therefrom.
    Any inquiries, correction or declaration of event related to personal data processed should be sent to: GDPR data request

    GDPR data request

    Thank you for your interest in BlueReg

    The file will be sent to you by email.

    Download your Case study