BioPharm International Supplements, April 2008 - BioPharm International

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BioPharm International Supplements, April 2008
Articles
Biopharmaceutical Contract Manufacturing: Contractor Selection by Market Segment
By William Downey
When a biopharmaceutical company pursues an outsourcing strategy, the choice of a contractor is a critical and strategic decision.
Outsourcing Laboratory Work—Establishing the Necessary Policies and Practices
By Joe Liscouski
The outsourced service provider should be considered an extension of your own laboratory.
How to Conduct an Audit of an Outsourcing Provider
By Andy McCallum
There are several considerations to keep in mind when auditing an outsourcing provider.
Working with a Contract Manufacturer: Key Considerations
By Giovanni Escobar
After a strategic evaluation of what activities to outsource, sponsor companies should follow key guidelines for selecting and auditing a provider and preparing quality agreements.
Devising an International Clinical Trial Distribution Strategy: Genentech's Approach
By Joe Jovero , Sue E. Steven, PhD
A decision-criteria matrix and cost models helped pinpoint the best distribution approach for the short- and long-term.

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