ProPharma Group, The Weinberg Group, and Southwood Research are now one family!  By combining our capabilities, we have become a regulatory services powerhouse, providing all of the services you need throughout the pharmaceutical product life cycle.

Using science as a driver, we help our clients achieve desired regulatory outcomes in Europe and the US in the most expeditious way possible, allowing them to realize the value of those outcomes sooner.

Navigating the generic drug application and approval process can be challenging for even the most experienced companies. From pre-filing through post-approval, our infographic lays out exactly what needs to be done and when to help ensure your Abbreviated New Drug Application (ANDA) remains on the path to success.

Obtaining marketing approval for a generic drug requires good data and a clear understanding of the regulatory milestones that need to be met and when that needs to happen.  Without both aspects, your generic drug application has little chance of remaining on schedule.

Most ANDA applications are rejected by the FDA on the first pass through the Agency, resulting in loss of both time and money.  For many reasons, it pays to get your product approved as quickly as possible.  How can you do that? The help of an experienced and reputable consultant is a great place to start.  

Are you curious about any of the following:

  • How is an ANDA different from an NDA? 
  • How to determine if your product needs a 505(j) or a 505(b)(2)?
  • What are FDA's stability requirements? 
  • How can The Weinberg Group help me through the generic drug process? 

The answers to these questions, plus a step-by-step guide through the entire approval process is all in our infographic.  Download the infographic today to learn how to successfully navigate FDA's generic drug approval process.