Including Regulatory at the Strategy Table
Posted 01 December 2010 | By
Transforming a controlled stream of high-quality raw materials into a steady output of products that delight an ever-increasing number of customers is the ultimate goal of any manufacturer. It becomes more critical in highly regulated businesses such as the pharmaceutical and medical device industries. Regulations provide frameworks intended to manage the constant tensions between attaining quality and containing costs. When done correctly, production can maintain a balance between quality and cost such that efficiencies lead to sustainable savings. In turn, those sustainable savings can fuel the development of capabilities to increase volume and diversity of product offerings. Within FDAregulated industries, this cycle of product flow must accommodate a growing number of regulatory requirements that are also increasing in complexity and scope. This is creating the downward spiral that is hindering many companies.