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

Case studies - 10 mai 2019

Expert CMC advices on quality dossier preparation in support of 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 (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.

Vous avez aimé cet article ? Partagez le sur les réseaux sociaux :

Download the
Case Study


Thank you for your reply

You can download the file below

Télécharger

Découvrez notre dernière étude de cas

En savoir plus