Developing an Effective Regulatory Strategy

| 01 December 2010

As the global regulatory environment becomes increasingly complex, companies can no longer rely on assumptions or duplicating previously successful strategies for any but the most straightforward new products. Instead, they should develop and document a customized regulatory strategy that takes into account shortand long-term corporate objectives, the current and projected regulatory environment during the course of product development and the needs of multiple stakeholders within and outside the company. This article lays out an approach for building a comprehensive regulatory strategy. While the overall approach is written with device development in mind, the principles may be adapted for other types of regulated products.


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