In the face of dwindling drug pipelines, complex regulations and block-busters crossing their patent exclusivity, mature products offer a revenue stream for companies to sustain their bottom lines in a hyper-competitive global market.
Pharmaceutical outsourcing is going through a major transition. Around 40 years ago, in the 1980s, pharmaceutical companies began using clinical research organizations in a more formal way to support the development process.
Initially, outsourcing was largely pursued as a means of reducing costs. Over time, outsourced labor gained knowledge and process expertise to manage complete processes.
Now outsourcing is entering a new phase – managing the mature portfolio. The “lift and shift” of resources and processes is now moving toward more strategic and integrated relationship-based models that combine regulatory and scientific expertise with operational and technological capabilities across the safety, regulatory and quality domains. In particular, companies are looking toward models to support the maintenance and strategic management of mature products, allowing them to focus on new product innovation while safeguarding and supporting their marketed portfolio. This ebook explores the unique organizational challenges pharmaceutical companies face with managing their mature products –meeting complex and diverse global regulatory requirements while keeping maintenance costs low and ensuring continuous innovation. It assesses how an integrated outsourcing model that has a flexible structure can promote innovation and continual improvement and strengthen quality assurance.