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1-2 of 2 results for Regulatory input to dossiers

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Select article: Organization and Responsibilities of the Chemistry,Manufacturing,and Controls Function within Regulatory Affairs: A Survey of 17 Companies

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First published 1998-4

Organization and Responsibilities of the Chemistry,Manufacturing,and Controls Function within Regulatory Affairs: A Survey of 17 Companies

Samuel T. Barnett, Roger W. Croswell, Anthony C. Cartwright [...]

Therapeutic Innovation & Regulatory Science

Select article: Regulatory and Development Issues in the Demonstration of Therapeutic Equivalence for Multisource Biotech-Derived Pharmaceuticals

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First published 2000-7

Regulatory and Development Issues in the Demonstration of Therapeutic Equivalence for Multisource Biotech-Derived Pharmaceuticals

Robert L. Zeid

Therapeutic Innovation & Regulatory Science

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