Risk Management Plans (RMP) have become an essential part of many marketing applications. For example, Risk Minimization and Pharmacovigilance plans are required by the European Medicines Agency for marketing approvals in the European Union. Additionally, a Risk Evaluation and Mitigation Strategy is sometimes required by the U.S. Food and Drug Administration for marketing approvals as well.
Creating these plans is a complex task and can put an enormous strain on a company’s resources. This is where Kendle's extensive background in preparing high-quality risk management documents can help. We can provide an efficient review of your adverse event profiles and can draw on our broad pre-clinical and toxicology knowledge to provide a comprehensive risk assessment as well as recommendations on options to reduce any identified risks.
We also are familiar with local regulations, ensuring that your RMP plan meets all local and regional regulatory requirements and helping your product to be approved as quickly as possible.