Juggling local affiliate complexity amid pharma globalization

The global pharmaceutical industry is going through a significant shift in the way it operates. Dr Stefanie Lietsch-Dallwig, senior director global program management - service solution lead Local Affiliate Services, at PharmaLex shares her insights on how this shift will impact the local affiliate model in an Expert View piece.

Globalization of the pharmaceutical industry has brought both opportunities and challenges. On one hand, this brings new and wider revenue streams. However, there is also a need to develop careful strategies to manage a strict, complex and often vastly differing global regulatory landscape.

Despite some efforts to harmonize, there remain different approaches to drug and device regulation from region to region in areas as wide ranging as safety, quality, administration and technology.