The marketing application is the ultimate goal of the development effort.  

Marketing Applications 

The marketing application provides comprehensive information about a drug, enabling regulatory agencies to assess quality, safety, and efficacy and evaluate the ability of the future license holder to ensure and monitor a sustainable benefit/risk ratio.

At Senita, we help our clients navigate, develop, and defend marketing applications, including New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorization Applications (MAA).

Marketing Application Services:

Advising on the overall regulatory submission strategy.

Identifying the marketing application timeline and content requirements.

Supporting the marketing application preparation process, including working collaboratively with other third parties to bring all aspects of the submission together.

Contact us today to learn how we can help you navigate the regulatory landscape and bring your innovative products to market faster.