Dear E,
Marketing application submissions, including NDAs, BLAs, and MAAs, are the culmination of years of research and the final hurdle before your product makes it to market. At Rho, our experts are passionate about developing high-quality marketing applications to help our clients accelerate their time to market, maximize research investments, and bring the benefit of new treatments to patients sooner.
Using our collaborative, cross-functional base of knowledge, our experts have compiled key points on regulatory strategy, data integration and readiness, plus electronic publishing that can help ensure a smooth marketing application submission.
Download this article to learn about:
- Early planning and preparation ideas
- Details regarding leveraging the IND in creation of the NDA
- How to start with the end in mind when it comes to data
- Considerations to make sure the product is approvable
- Suggestions for creating a target product profile
- Preparation for your End of Phase 2 (EOP2) meeting
- Creating and maintaining a
living
clinical database
