BlueReg Group
About BlueReg Group
Categories
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Country/Region:France
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On CPHI since:2019
Products from BlueReg Group (1)
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Product CMC Services - Chemistry, Manufacturing and Controls
BlueReg has a dedicated team of CMC consultants with significant expertise in all areas of CMC development.
Our experts can advise you on pharmaceutical development strategy and provide oversight for the overall product development process to ensure key development milestones are successfully re...
BlueReg Group Resources (1)
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Brochure 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.
