Safety reports

BlueReg has extensive experience in writing safety documents in a wide variety of settings and different stages of the product lifecycle.

 

The experienced team can support with assessing a product risk benefit profile and writing a Risk Management Plan (RMP), Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report  (PBRER) and early access reports. Furthermore, BlueReg can provide support to update the Summary of Product Characteristics (SmPC) for safety reasons.

 

All these activities are carried out in full compliance with Good Vigilance Practices and local standards.

Our experts

Our team can also support you through the entire application process from development, to registration and post-approval management

Dominique Patrone

Marie Regnat Sauvageon

Associated services

Worldwide

BlueReg consultants can help navigate International regulations and provide support and advice for all your project requirements

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