Regulatory and Safety Integration
An Integrated Model Approach to Improve the Management of Marketed Products
White Paper

Biopharma companies face significant complexity working in a global environment governed by rigorous regulatory and safety requirements that vary by market. Understanding and managing local regulatory requirements presents a significant burden. Few companies are able to fully maintain a current global regulatory intelligence database that captures all local variations and updates. Many companies struggle to maintain core data sheets, safety information and labels aligned globally. Likewise, few companies have fully scalable infrastructure to handle rapid increases in safety related activities and risk management. To effectively manage your portfolio, you need to do more than simply meet regulatory requirements. By aligning all aspects of marketed product maintenance, including regulatory, safety and benefit-risk management, you can improve compliance, and reduce complexity and cost.


To respond to the challenges of today’s healthcare environment — including growing regulatory, financial, development and regional pressures — biopharma companies must optimize resource allocations. While promising new products are an obvious place to invest, established marketed products cannot be ignored; as products age, the pressures to shrink maintenance costs and grow or maintain revenue continue to increase — all while ensuring regulatory compliance and reducing risk (Figure 1). These dynamics present unique challenges for managing established products and require innovative and cost-effective approaches that help ensure patient safety and compliance while continuing to meet ever-increasing regulatory demands.


Biopharma companies are facing an increasingly complex environment for established products, including:
    Significant cost to maintain — High degree of fixed assets in high-cost regions, coupled with little or no visibility to actual costs/activities in LOCs
  • Limited resource pool — The same pool of resource is ensuring that innovative products are marketed and that established portfolio are compliant
  • Heightened focus on data — Regulators are demanding that companies supply both more information and greater data consistency
  • Evolving emerging market regulations — Emerging markets are rapidly increasing their expectations about regulatory documentation, impacting established products
  • Increased emphasis on risk assessments — Evolving regulatory requirements for marketed products, including EU GVP requirements for ongoing benefitrisk assessments

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