FDA Advisory Committee and EMA Oral Explanation Meeting Support
Millions of dollars are riding on your FDA Advisory Committee Meeting/EMA Oral Explanation Meeting. Any misstep can affect the likelihood and timing of approval. Be prepared.
We can help you navigate today’s stringent clinical and regulatory requirements as well as to successfully communicate complex scientific information that affects business outcomes. Our leadership in this area has resulted in reduced product approval cycle times and has enhanced business performance. In addition, our services are demanded by companies seeking to enhance their product portfolios and move forward in the competitive health care marketplace.
- FDA Advisory Committee and Device Panel Meetings
- EMA Oral Explanation Meetings
- Other regulatory strategy, submissions, and meetings
- KOL and advocacy development
- Clinical strategy and implementation
- Rx-to-OTC switch
Lumanity can help ensure a timely approval by providing an integrated approach to managing all aspects of an FDA Advisory Committee/EMA Oral Explanation Meeting for your product. We provide a one-stop solution for all of the critical elements related to your mission and deliver the highest-quality services. Our professional regulatory focus, combined with our extensive relationships with key opinion leaders (KOLs) will help to ensure Advisory Committee success.
Lumanity provides an integrated approach to managing all aspects of key regulatory meetings
- Scientific data review
- Regulatory strategy
- Definition, testing, and implementation of key messages
- Support the development and creation of key deliverables (core presentation, briefing book, backup slides)
- Identification of experts (speakers, mock panelists)
- Speaker training
- Open public session
- Meeting logistics
What Makes Us Different?
We are a team of scientists, regulatory strategists, and consultants:
- Scientists: PhD, PharmD, MD
- Specialists: Regulatory Affairs Certification (RAC) holder, MPH
- Extensive/relevant relationships with KOLs in most therapeutic areas
- Communications professionals
Lumanity is a recognized expert in priority review, accelerated review, 505(b)(2), biosimilars, Animal Rule, Risk Evaluation and Mitigation Strategies (REMS), opioid abuse/addiction, and device panel reviews for a broad range of therapeutic areas:
- Gene therapy
- Infectious diseases
- Rare diseases
- Women’s health
Lumanity can be counted on for service and quality. We utilize proven processes supported by technologically advanced resources to provide you with high-quality services.