Case studies - 10 mai 2019
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.
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