Medical writing services

 

MedexPV has managed numerous medical writing projects. We are recognized by our clients for excellent skills in presenting elaborate data in a clear and concise scientific manner. We have authored and /or medically reviewed many aggregate safety reports. Our expertise  and experience in medical writing covers multiple therapeutic areas, including neurology, psychiatry, orphan diseases, and many more 

 

We offer the following medical writing services:

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• Periodic Benefit Risk Evaluation reports/Periodic Safety Update Reports (PBRER/PSUR)

• Developmental Safety Update Reports (DSUR)

• Periodic Adverse Drug Experience Reports (PADER) 

• Addendums to Clinical Overview

• Risk Management Plans

• Clinical Assessment Reports

• Issue -related reports 

• PBRER follow up measure reports (PRAC requests)

• Signal Assessment Reports

• 2.5 Clinical Overviews

• Ad-Hoc Safety reviews

• Response to Regulatory Authority Questions documents

• Medical and scientific literature reviews

 

To discuss your medical writing requirements, please contact us.

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