The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals Books
Product Description
(Kluwer Academic) BioPharmaceutical Quality Solutions, Carlsbad, CA. Provides insight and matter-of-fact suggesting in a common sense business approach for administration the Chemistry, Manufacturing & Controls (CMC) regulatory compliance requirements for biopharmaceuticals. Clarifies the biopharmaceutical CMC regulatory compliance, strategy development, and more.
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A excellent overview of points to consider for drafting CMC sections. I found the level detail adequate to provide the necessary background, without being so rough that it place me to sleep. The section on CMO’s is particularly excellent for those who have small or no experience with Narrow Manufacturing.
Rating: 5 / 5