ABSTRACT
The recent wave of mergers and buyouts in the pharmaceutical industry has combined companies with a spectrum of different cultures and philosophies. While some of these differences are very evident (i.e., Japanese and American company joint ventures), even two companies who appear on the surface to be very similar often have very different philosophies. Differences in regulatory and manufacturing philosophies may be very evident. Even though both companies may be in compliance with the regulations and guidelines, each may implement the regulations and guidances very differently. This is often due to differences in corporate philosophies and culture and the experience of each company with var ious regulatory bodies and their reviewers.
