While global harmonisation remains the holy grail, the reality is that pharmaceutical companies still face significant challenges navigating regulatory differences. Stefanie Lietsch-Dallwig considers whether changes to the local affiliate model could ease the load.
A Strategic Approach To Local Affiliates In The Global Era
With the rapid evolution of the global regulatory environment, pharmaceutical companies must deal with increasingly complex and often competing demands in key markets.
A Strategic Approach To Local Affiliates In The Global Era
Industry has traditionally relied on local affiliates to ensure compliance with mandatory regulatory or legal requirements in each region or country. A large pharmaceutical company can typically have as many as 100 operating companies or affiliates around the world to help manage its growing portfolio of mature products.1 But growth brings its own pressures, increasing not only the amount of work required by local affiliates, but the volume and type of that work.
A Strategic Approach To Local Affiliates In The Global Era
This global shift has been brought about, in part, by an unprecedented demand for innovative therapies, new ways of working, supply chain pressures, changes in the dynamics of research and development (R&D) and a move towards telemedicine and digital health.
A Strategic Approach To Local Affiliates In The Global Era
Local affiliates are often stretched beyond their capabilities, a situation amplified by increasing shortages in expertise across the industry, exposing companies to significant risk. Compliance with applicable laws and regulations, which vary according to market or region, is mandatory and failure to comply can lead to critical regulatory action, considerable financial impact and reputational damage.2
A Strategic Approach To Local Affiliates In The Global Era
As analysts have noted, heightened regulation in smaller markets requires companies to have suitable compliance resources to ensure compliance standards are not compromised.2 It is crucial companies evaluate the way they operate at the local level to reduce risk and invest…
A Strategic Approach To Local Affiliates In The Global Era
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