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BlueReg Group ATU & Exploitant

Case studies

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7 January 2021

Temporary Authorisation for Use (ATU) in France

A French pharmaceutical affiliate entrusted BlueReg to support them for the whole process of submission (advice, writing activities and support for meeting with the Competent Authorities) of a cohort Temporary Authorisation for Use (cATU) request to the ANSM for a…

Case studies

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16 December 2020

Implementation of a French Early Access Program for orphan drug patients in nominative & cohort program

A European pharmaceutical company entrusted PharmaBlue (a BlueReg Company) as French «exploitant» with the responsibility of submitting, obtaining and implementing a French Early Access Program called “ATU” (Autorisation Temporaire d’Utilisation) for its orphan drug for patients in nominative and cohort…

Case studies

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4 June 2020

Supply Shortage Management Plan

A French pharmaceutical firm (generic products) was directed by the French Health Authorities to prepare a Supply Shortage Management Plan (SSMP) for one of its medicinal products used in the context of a temporary recommendation for use*.  This was a…

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Composed of proven experts from the pharmaceutical industry, our team is ready to answer to your needs in any area of product development, commercialisation and early access programs, and life cycle management

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Welcome to BlueReg, an international consulting company for the pharmaceutical industry, specializing in development, regulatory affairs, economic affairs, quality and pharmacovigilance. We have built long-term partnerships with many clients by offering them “tailor-made” services guaranteeing expert advice and efficient solutions, thus supporting their projects towards success.

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