New Release at the PDA Bookstore
Pharmaceutical Outsourcing: Quality Management and Project Delivery
Edited by Trevor Deeks, Karen Ginsbury and Susan Schniepp
Item No. 17316
Many companies are looking to contract providers for managing various aspects of the drug development process. Contract organizations have services that range from research activities to clinical trial management and oversight to manufacturing of the clinical supplies and commercial product to packaging and labeling as well as product testing. Virtual companies may have multiple contracts with multiple service providers for multiple phases of the drug development process and the drug manufacturing process. To complicate the matter, there is little guidance from regulatory authorities regarding the use of contract providers. This book is intended to set forth and explore the best practices for contract organizations from various perspectives: the contract organization, the contracting organization and the regulators.
www.pda.org/outsourcing The PDA
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