How a Two-Part NDA Regulatory Strategy Resulted in Submission Success

How a Two-Part NDA Regulatory Strategy Resulted in Submission Success Image

Developing a New Drug Application (NDA) for submission to the FDA is an extremely complex process and one that can present challenges to even the most seasoned professionals. From ensuring you have the right people on your team to developing an appropriate submission strategy and so much more, ProPharma's regulatory sciences experts can help with any of your regulatory submission needs across the globe.

Learn how ProPharma can help develop and execute a regulatory strategy for your submissions, helping you achieve successful interactions with regulatory agencies across the globe.

Case Study


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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...

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Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

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

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Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...