
The challenges to effect technology transfer in a timely fashion, within budget and achieving savings that have probably been pre-commirted, at the requisite quality are approximately the same for each aspect. This guide provides a "ready reckoner" of the issues to be considered to achieve these objectives, ensuring that the regulatory issues from both a licensing and inspection
perspective are addressed, and maintaining the organisation's integrity for its products and with its shareholders. In considering the technology transfer process reference is made to the situation within the European Union (EU) in the main; however, where useful guides or proposals are available from other regulatory authorities, notably the FDA, these have been included for completeness.
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