While development of promising new products is an obvious area of focus for biopharmaceutical companies, maintenance of already established marketed products is a critical activity that cannot be ignored. As products mature, there is high pressure to grow or sustain revenue from established products whilst keeping maintenance costs low. Ensuring regulatory compliance and reducing product risk whilst still working within the cost constraints presents unique challenges to companies in managing established products and require innovative and cost-effective approaches that can help ensure patient safety and compliance while continuing to meet ever-increasing and complex regulatory demands. It is imperative for marketing authorization holders (MAH) to analyze their existing operating models for maintaining mature products and consider how they can benefit from an integrated safety, regulatory and benefit-risk model.
Download the whitepaper to learn a pragmatic approach to successfully navigating the Safety and Regulatory continuum.