Outsourcing regulatory lifecycle management: drivers, challenges and considerations

Delegating responsibility for effective planning and delivery of lifecycle management of all or a significant portion of global marketing authorizations is a decision that requires careful evaluation. It is anticipated that this model will continue to grow over the next few years and evolve to an industry norm for large and midsized pharma companies in the same way that other critical development activity is currently outsourced. This paper discusses how early engagement, development of mutual trust and a healthy partnership culture are keys to success.

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