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.