Expert CMC advice on quality dossier preparation in support of a Compassionate Use Program in France.

Case studies - 28 May 2019

BlueReg Group / Case studies / Expert CMC advice on quality dossier preparation in support of a Compassionate Use Program in France.

Expert CMC advice on quality dossier preparation in support of a Compassionate Use Program in France.

In the context of PRIME, a European biotechnological company entrusted BlueReg CMC team with the task of bringing the available quality data package of a synthetic peptide to global registration prerequisites for the next steps of development (the Compassionate use program in France, Phase III global program, registration in Europe and US) and to write the Quality part of the IMPD for early access submission in France.

 

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