• Maintenance of Mature and Generic Products

    White Papers
    Sep. 18, 2019

    While development of promising new products is an obvious area of focus for big pharma, there is also great pressure to grow or sustain revenue from established/mature products whilst keeping maintenance costs low. This whitepaper discusses how regulatory compliance and reducing product risk can be achieved whilst still working within these cost constraints. It also lays out why marketing authorization holders (MAH) should analyze their existing operating models for maintaining mature products and how they can benefit from an integrated safety, regulatory and benefit-risk model.

    While development of promising new products is an obvious area of focus for big pharma, there is also great pressure to grow or sustain revenue from established/mature products whilst keeping maintenance costs low. This whitepaper discusses how regulatory compliance and reducing product risk can be achieved whilst still working within these cost constraints. It also lays out why marketing authorization holders (MAH) should analyze their existing operating models for maintaining mature products and how they can benefit from an integrated safety, regulatory and benefit-risk model.