Postmarketing Writing Services to Help You Meet Regulatory Requirements
The Risk Management Plan (RMP) is the scientific living document that accompanies a product throughout its lifecycle. In the RMP, everything about the product comes together, safety risks are identified and updated, and all actions/events regarding efficacy and safety are reflected.
Together with our non-clinical, clinical, and quality teams, our pharmacovigilance (PV) specialists guide you through the process of developing and maintaining a quality RMP that meets all regulatory requirements.
Wide-Ranging Pharmacovigilance Expertise
At ProPharma Group, we ensure that you meet all requirements in developing and maintaining your RMP. We help you set up your RMP to identify and characterize the risks of a medicinal product in a concise and efficient manner, saving you valuable time when interacting with the regulatory authorities. We assist you in reflecting and implementing postmarketing obligations that are to be included in the RMP, including developing or reviewing educational material and risk minimization measures (RMMs), as needed.