Risk Management Plans (RMPs)

Coordinating with different departments in your company, we develop efficient Risk Management Plans for your products

  • identifying known risks associated with a product
  • discussion unknown risks
  • planing appropriate measures for risk reduction and
  • monitoring their effectiveness


Risk Management Plans

Following the implementation of the EU pharma package in 2012, a Risk Management Plan needs to be submitted with every marketing authorisation application, even for generic applications. The complexity of a Risk Management Plan must be adequate in view of the nature and safety profile of a particular product.