FDA Submissions

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FDA Submissions

FDA Submission Process

Compiling an FDA submission is not easy. The regulatory submission process is complex and time-consuming, and if the submission contains mistakes or inaccurate information, your product’s future may be at risk. However, if you put in the hours to make sure the submission is error free, the regulatory process will be much easier and your time-to-market will likely be much shorter.

The Weinberg Group: FDA Submission Experts

In order to make sure you get it right the first time, The Weinberg Group will combine our knowledge and 37 years of experience to plan and coordinate every detail of a clear and complete FDA submission. There are many elements that go into the regulatory submission, but most importantly, a combination of administrative and technical information must be accurately presented to prevent any delays or issues during the review stage.

FDA Submission Services

The Weinberg Group offers expert guidance and regulatory submission support throughout the entire submission process. We’ll utilize our extensive experience and strong relationship with the FDA to ensure a seamless submission process. We provide consulting services for key FDA regulatory submissions including:

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.

The Weinberg Group: IND Submission Experts

The Weinberg Group’s experts 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.

Learn more about our IND Submission services

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.

Choosing the Right Regulatory Pathway: 505(b)(1) vs. 505(b)(2)

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.  What is the difference between the two?

  • 505(b)(1) is the traditional regulatory pathway for NDA submissions. The 505(b)(1) pathway is used when seeking approval of a new drug without reference to or reliance upon non-proprietary clinical or nonclinical studies.  Sponsors submitting a 505(b)(1) NDA must demonstrate the safety and efficacy of the drug and are required to conduct all studies necessary to do so.
  • The 505(b)(2) pathway is used by Sponsors seeking approval of a new drug which is made up of active ingredients that are similar to a previously approved drug or in which there are scientifically credible published studies.  When submitting an 505(b)(2) NDA submission, Sponsors can rely, at least partially, on data used to support the Agency’s findings of safety and effectiveness related to a similar product that has been previously approved by the FDA.

It is extremely important that this is not approached lightly and that all precautionary measures are taken to ensure that you are headed in the right direction.  The Weinberg Group can help you do this.

The Weinberg Group: NDA Regulatory Experts

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.

The Weinberg Group will work with you, guiding you through the entire process of preparing and submitting your NDA using our vast knowledge of, and past experience with, the FDA to create a seamless filing process.

Learn more about our NDA submission services

Obtaining orphan drug designation can be challenging, and simply obtaining the designation is not always enough. In order to really make a difference, that knowledge must be translated in your regulatory and drug development efforts.  The Weinberg Group can help you accomplish this.

We will work with you to determine whether your product is eligible for orphan designation, using all relevant documents, including product information, scientific articles, public-domain information, disease prevalence data, etc., to come to our final verdict.  If we recommend proceeding with the application, we will work with you to develop and submit a complete application that builds upon the information obtained through our evaluation of the research.

Learn more about our Orphan Drug Designation submission services


No matter where you are in the regulatory submission process, The Weinberg Group can help you reach your next milestone and achieve a successful interaction with the FDA.

To learn more about how The Weinberg Group can help you develop a reviewable, complete FDA submission, contact us today.