Outsourcing pharmaceutical industry/custom

Pharmaceutical companies usually have to provide capacity for the new product before the new product is approved. Sometimes, this initial production capacity may be outsourced to a custom manufacturer. In fact, outsourcing has become more important to the pharmaceutical industry as pharmaceutical companies focus internal resources on developing new products, and take advantage of the manufacturing capacity of external sources for both initial and also long-term production capacity. 

The subject of outsourcing, specifically the custom manufacturing of pharmaceutical fine ehemicals, is dealt with extensively in Peter Poliak, Fine Chemicals - The Industry and the Business, Wiley,... 

In addition, a reality of the pharmaceutical industry at present is the outsourcing of some of all of the synthetic chemistry for a project. To the list of existing questions must be added several others. Which contract research organization(s) will you choose, and what can they be expected to accomplish How will you handle electronic lab notebooks, documenting intellectual property issues and other legal issues How do you handle the logistics of quality assurance, shipping, and customs To help you address each of these, it is prudent to reach out into your broader network to get opinions from others not only in your company but also across the industry. 

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