References

Coordination of remediation actions for a Global Regulatory Affairs department

Project outline

  • To facilitate the preparation of an MHRA Pharmacovigilance inspection, Pagamon provides methodological and operational support to the Global Regulatory Affairs department (GRA)
  • GRA and pharmacovigilance must address operational gaps and prepare for inspection by MHRA.

Project approach

  • Definition of priorities and actions to be taken.
  • Development of tools for project PMO.
  • Preparation and writing of action and implementation plans.
  • Task tracking, management support and regular reporting.
  • Facilitation of collaborative work.
  • Support in writing deliverables.

Results

  • Objectives set for the remediation of identified pain points are achieved before the deadline (MHRA inspection).
  • Medium and long-term improvement of GRA’s department management.

    Pagamon is a strategy and transformation consulting firm founded in 2013. We support major players in the industry, services and life sciences sectors in their search for balance. Helping them structure their strategic vision, transform their operational and/or digital model, and drive change. To support profitable, sustainable and responsible growth. As a committed player, Pagamon leads the Observatory of the Balanced Organization™, articulated around a "think tank" and an annual survey. In order to provide an innovative, sometimes offbeat, perspective on the strategic and operational implementation of transformations to support the growth of companies.