X Pharma Plus helps pharmaceutical companies develop and implement Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) to identify, monitor, and minimize patient risks throughout drug development and post-marketing. Our experienced team provides end-to-end support, from strategy development to implementation and continuous updates.
Risk Management Pharmacovigilance Services – Overview
Risk Management Plans (RMPs) in the EU and REMS in the US guide companies in minimizing patient risks associated with medicinal products.
Comprehensive safety packages are required for new marketing applications, detailing potential risks, missing information, and risk minimization strategies throughout the product lifecycle.
Focuses on risk communication and safe use measures, including medication guides, communication plans, ETASU (Elements to Assure Safe Use), implementation systems, and submission timetables.
X Pharma Plus provides global support for developing, implementing, and updating RMPs and REMS programs, ensuring compliance with regulatory requirements and patient safety standards.
Risk Management Pharmacovigilance Services
“Development and implementation of Risk Management Plans (RMPs), REMS, and risk minimization measures to proactively identify, assess, and mitigate product-related safety risks.”