Some of the most important points in a company’s history is the interactions and meetings with FDA. These meetings could be introducing the medical device or biologic to the FDA or arguing for approval of the technology. All meetings are critical to a company’s success and MCRA has a history of having successful meetings at all levels of FDA. MCRA has expertise to assist companies with:
- Represent clients in interactions with FDA
- Assist with preparations for FDA meetings such as pre-submission meetings and “day 100” meetings
- Develop presentations for FDA meetings
- Prepare clients for Advisory Panel meetings
- Prepare mock panels
- Prepare and strategize panel presentations
- Prepare and strategize panel question responses
- Prepare and strategize executive summary
- Advise on regulatory options and potential pathways
- Prepare clients for various Type A-C meetings