Pharmaceutical Submissions

You’ve worked hard; your extensive preparation and careful execution paid off and your Pre-IND Meeting went exactly as planned. You’re ready to move forward with your clinical trials and obtaining an FDA cleared Investigational New Drug (IND) submission is the first step in being able to do this.

The sooner you can begin your clinical trials, the sooner you will be able to market your product. However, you can’t begin your clinical trials until FDA determines there are no grounds for a clinical hold. In order to prevent any obstacles from coming up during this process, it is critical that your IND submission includes all required information and is free from any errors.

Experts at Krystol Consulting will work with you to develop and submit a successful IND application. Together, we will carefully review the IND application and our staff will provide you with a final copy that is FDA ready.

You have successfully navigated almost all of the milestones required to obtain FDA approval and are finally ready to approach the final steps in the process.  Before your product can be marketed in the United States, you must submit a New Drug Application (NDA) and obtain NDA approval from the FDA.

Preparing an NDA is a very rigorous, time consuming, and expensive process, and the first step is deciding which regulatory pathway to follow. There are two regulatory pathways to choose from when preparing an NDA – 505(b)(1) and 505(b)(2). Choosing the right one is critical to the success of your submission.

We have a proven track record of helping our clients obtain NDA approval by determining the appropriate regulatory pathway and assisting with the development and submission of the application to the FDA.