FDA Regulatory Submission Process and Guidance

FDA Regulatory Submission Process

Compiling a Food and Drug Administration (FDA) regulatory 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 regulatory submission is error-free, the process will be much easier, and your time-to-market will likely be much shorter.

ProPharma Group: FDA Regulatory Submission Experts

In order to make sure you get it right the first time, ProPharma Group will combine our knowledge and more than 30 years of experience to plan and coordinate every detail of a clear and complete FDA submission. Many elements go into the submission, and any inaccuracies in administrative or technical information can lead to delays and issues during the review stage of the regulatory submission process. To ensure no such issues occur, ProPharma Group can help with the preparation of your FDA regulatory submission.

FDA Regulatory Submission Services

ProPharma 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:

Investigational New Drug (IND) Submission Guidance

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 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 the 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.

ProPharma Group: IND Submission Experts

ProPharma 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.

New Drug Application (NDA) Submission Guidance

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 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 a new drug’s approval without relying upon non-proprietary clinical or nonclinical studies. Sponsors submitting a 505(b)(1) NDA must demonstrate the drug’s safety and efficacy 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 similar to a previously approved drug or in which there are scientifically credible published studies. When submitting a 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 imperative that this is not approached lightly and that all precautionary measures are taken to ensure that you are headed in the right direction. ProPharma Group can help you do this.

ProPharma 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 developing and submitting the application to the FDA.

ProPharma 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.

Abbreviated New Drug Application (ANDA) Submission Guidance

You have developed a generic drug product. To market the product for sale in the United States, an ANDA must be reviewed and approved by the FDA.

Before your ANDA is submitted to FDA, you must be certain your product is bioequivalent to the Reference Listed Drug (RLD). Doing this can be challenging, but ProPharma Group’s experts are here to help. We will assist you through the entire ANDA submission and approval process with the FDA, from ensuring your product meets the bioequivalency requirements to developing a submission strategy and compiling and submitting your application.

Learn more about our ANDA submission services.

Orphan Drug Designation (ODD) Submission Guidance

Obtaining orphan designation can be challenging, and simply obtaining the designation is not always enough. To really make a difference, that knowledge must be translated into your regulatory and drug development efforts. ProPharma 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 ODD submission services.

Get Expert Guidance for Your Next FDA Regulatory Submission

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

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

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