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.
FDA GUIDANCE – COVID-19
BlueReg continues to monitor the changes in the regulatory guidance and we wish to share...
How antibody testing can help us fight COVID-19 ?
There is a high demand around the need for antibody testing and the media frenzy...
BlueReg continues to expand in the US opening its second North American office in Boston
Cambridge, Massachusetts, USA, December 13 2019, BlueReg, the consulting organization for life sciences companies, is...