A Risk Management Plan (RMP) includes a summary of important identified risks, potential risks and missing information. This serves as the basis for building an action plan for Pharmacovigilance activities and risk minimisation.
We can review your current documents or prepare new ones ready for submission. We have extensive experience in preparing high quality RMPs to ensure compliance with requirements.
Since the coming into force of the new EU PV legislation a RMP is mandatory for all products.
If you want to dicuss how you can be safe in our hands, please contact us for a consultation.
Telephone: +353 125 44033