Pharmaceutical Outsourcing: Quality Management and Project Delivery

Intended to set forth and explore the best practices for contract organizations from various perspectives: the contract organization, the contracting organization and the regulators. There has been a significant amount of activity and growth in contract operations. 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, and the relationship between a client and a contract provider is important and complex. The editors and authors of Pharmaceutical Outsourcing: Quality Management and Project Delivery have experience with outsourcing and agreed to collaboratively publish a comprehensive, practical guide with the goal of offering sound, reasonable advice to the outsourcing community focusing mainly on contract manufacturing.