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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals John Geigert Fifth Edition 2026 edition
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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
John Geigert
Regulatory authorities, primarily the U. S. FDA and the European EMA, have responded to this increasing CMC regulatory compliance complexity of biopharmaceuticals, and have issued over 150 new or updated regulatory guidelines since the publishing of the previous edition.
| Media | Books Hardcover Book (Book with hard spine and cover) |
| Released | July 3, 2026 |
| ISBN13 | 9783032252821 |
| Publishers | Springer Nature Switzerland AG |
| Pages | 629 |
| Dimensions | 150 × 220 × 20 mm · 1.14 kg |
| Language | German |