Navitas Risk Assessments: Proactively manage regulatory and corporate compliance in your affiliates

The pharmacovigilance regulatory landscape is continually evolving across the world, and MAHs need to maintain oversight of patient safety in all markets where products are developed and licensed. At times, affiliates make reactive, market-specific commitments at the local level without having the necessary support systems, resources, or tools in place to keep the global organization informed of changes or deviations to standard procedures. Over time, these deviations accumulate and can pose significant risks to operating an effective and compliant PV system. Detecting and addressing these types of systemic and local / regional challenges can be supported through a risk assessment that quickly uncovers gaps, deviations, and risks against regulatory requirements as well as unmet expectations from the corporate organization.

What the Risk Assessment includes

Our standardized questionnaires can be tailored for your organization and cover a broad range of topics including:

  • Organization
  • Regulatory Intelligence
  • QMS
  • Governance
  • Agreements / Contracts and Third Party Management
  • Data Collection Programs and Studies
  • Training
  • IT Landscape
  • Social Media


Benefits – how Navitas can help

  • Accelerated assessment leveraging our analysis tools, such as heat maps, allowing for the quick identification of patterns in systemic, regional, and local risks
  • Mitigation plan to overcome regional and corporate compliance risk in the short and long-term
  • Development of a fit-for-purpose risk management strategy and governance framework
  • Implementation of dashboards for continued monitoring to ensure the successful roll-out of the risk management strategy

For more information on affiliate risk assessments please download our case study or contact, at This email address is being protected from spambots. You need JavaScript enabled to view it.

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