Prepare for Launch
Incorporate Real-World Evidence for FDA and EMA Regulatory Compliance
Gathering appropriate real-world data is critical, but your RWE strategy success relies on presenting a compelling value story backed by scientifically rigorous evidence. Our team of experts has extensive experience preparing cohesive and comprehensive communication tools that will resonate with your audiences. We are highly familiar with US and EMA regulatory requirements to help you incorporate real-world evidence with confidence as you navigate those processes. Because product launch is not the end of your product journey, we also have experts who can provide advice and early planning to help you be prepared for possible post-authorization safety commitments or ICER evaluations.
We can help you:
- Finalize GVD and AMCP dossiers
- Prepare economic sections of HTA or formulary submissions
- Implement RWE strategy
- Value differentiation studies
- Prepare market access tools and objection handler training
- Prepare for ICER evaluations
- Prepare for regulatory post-authorization safety and effectiveness commitments
