How to Compile a Science-Backed New Drug Application (NDA) Submission

Developing a successful NDA is critical to the success of your product and company. Learn how to develop a science-focused submission like an expert with these six tips.
You are getting ready to begin the process of compiling and submitting your NDA to the FDA. It has taken years of hard work to get to this point, but it is all paying off because you're finally here. With all of the resources that have been poured into your product over the years, it would be tragic for all your efforts to be derailed at this point.
This is a critical milestone in drug development and failure at this point could be detrimental to your entire company. To help you avoid this situation, our experts are laying out six of our best-kept secrets for compiling an NDA submission like a pro. Learn how to develop a science-focused application like an expert with our six tips for success.

Thanks for your submission

Download Whitepaper



The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...


Free Webinar: Effective FDA Engagement

FDA faces challenges (like new technology) and new review models (like real world evidence) that stretch agency standards and practices. At the same time, imperatives like product safety and efficacy...


Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...