Essential guide to post-approval regulatory lifecycle maintenance
Global-to-local outsourcing approaches to improve efficiencies and reduce costs for established products
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Global-to-local outsourcing approaches to improve efficiencies and reduce costs for established products
Fill in the form to get your free guide
Growing regulatory complexity and mounting cost pressures mean that biopharmaceutical companies can struggle to sustain post-launch product revenue streams in today’s hyper-competitive global markets. More than ever, organizations are looking to strategically outsource the regulatory lifecycle management of their established products to help manage compliance risk and reduce costs, freeing up key internal personnel to focus on strategic projects.
While large companies – often with as many as 100 operating companies or affiliates worldwide – have long been leaders in outsourcing post-approval regulatory affairs, we have observed a sharp increase in small and mid-sized companies seeking the same benefits.
This guide explores best practices and case studies of how biopharmaceutical companies of all sizes are effectively outsourcing post-approval regulatory lifecycle management, creating dynamic organizational agility that can drive long-term strategic advantage in global markets.
By partnering with domain experts and applying a holistic outsourcing approach product that harmonizes regulatory management from the corporate to the regional and local affiliate levels, these companies are sustaining revenue streams and achieving greater efficiencies. What’s more, they are generating opportunities to expand market access and drive higher return on investment from established product portfolios.