Global footprint considerations for outsourced RI support Global footprint considerations for outsourced RI support Outsourcing regulatory intelligence (RI) has emerged as a significant strategy for pharmaceutical and biotech companies aiming to navigate the complex landscape of regulatory compliance effectively. This article serves as a comprehensive regulatory explainer manual for understanding the implications of outsourcing regulatory intelligence versus maintaining an in-house function, focusing on both cost and ROI analysis, governance structures, and hybrid model considerations in the context of US, EU, and UK regulations. Context The role of regulatory affairs (RA) is pivotal in ensuring that pharmaceuticals and biologics meet all…