Regulatory Strategy & Submissions

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Regulatory Strategy & Submissions

Whether this is the first or tenth product you have brought to market, careful preparation for each milestone and possible challenge is necessary or your entire development strategy could be derailed. Planning is key to this process, and knowledge of each regulatory agency’s intricacies is a major plus.

Whether you need help executing your entire regulatory strategy, producing an FDA briefing package, or conducting a Pre-IND Meeting, The Weinberg Group’s experience and positive working relationship with the FDA means we will get the job done right. We work with you to do what is necessary to move to the next milestone.

Our Project-Based Regulatory Strategy and Submission Services Include:

  • Regulatory Strategy
  • FDA Meetings
    • Pre-IND Meeting
      • To the best extent possible, any meeting with the FDA should end in clarity.  During the Pre-IND Meeting Sponsors have the chance to discuss the requirements for opening an IND with the Agency.
    • End of Phase 2 Meeting
      • During this meeting, you need to effectively present your Phase 3 and submission strategy and ensure that you are aligned with the FDA prior to the start of Phase 3.
    • Pre-NDA Meeting
      • When you leave your Pre-NDA Meeting, you should have an understanding of the FDA’s expectation for content.
      • During the Pre-NDA Meeting, you must make the most of the opportunity to solicit comments and clarification from the FDA on the acceptability of:
        • Pivotal clinical data, including late-breaking data that might become available for submission during the FDA’s review of the NDA
        • CMC information and, in particular, the extent of stability data
        • Content of the ISE and ISS sections
    • FDA Advisory Committee Meetings
      • Each Advisory Committee is different and has specific needs and concerns, and you must keep these in mind as you discuss your product.
    • Medical Device Pre-Submission Meeting
      • Attending a Pre-Submission meeting with the FDA provides sponsors with the opportunity to obtain feedback from the Agency before submitting an application.
      • They are not required, but are strongly recommended by both the FDA and The Weinberg Group. Let us help you prepare for and conduct a successful Pre-Submission Meeting with the FDA.
    • Medical Device Submission Issue Meeting
      • When done correctly, a Sponsors should leave a Submission Issue Meeting with the  feedback and clarification necessary to re-submit a successful application.
      • Let us help make sure the meeting is conducted the right way, helping you get as much information as possible.
    • Medical Device Informational Meeting
    • PMA Day 100 Meeting
  • FDA Submissions
    • IND Submission
      • The sooner you can begin your clinical trials, the sooner your product will be on the market, and in order to prevent any hiccups in this process, your final IND submission must be error free and contain all of the required information.
    • NDA Submission: 505(b)(1) and 505(b)(2) Assistance
      • As you can imagine, this type of submission requires extensive research, including both clinical and nonclinical studies to prove the product’s safety and efficacy for the indication being sought.
    • Orphan Designation
    • ANDA Submission
      • Nearly 90% of ANDAs are not accepted by the FDA for review on the first pass. We have the knowledge and expertise you need to increase your chances of beating the odds, saving you both time and resources.
    • IDE Submission
      • Similar to an IND for drugs, medical device manufacturers must obtain IDE approval prior to initiating clinical trials. However, the absence of any formal, pre-printed forms can make IDE submissions increasingly difficult. Our experts have the experience you need to obtain approval as quickly as possible so you can continue with the development of your device.
    • 513(g) Request for Information
      • Before a device can be marketed, manufacturers must prepare and submit a marketing application to the FDA.  The specific application that must be submitted is determined based on the device’s class, so knowing FDA agrees with your classification before beginning to work on the application will help increase your confidence when submitting your finished application.
    • 510(k) Submission
      • Over the last 35 years, The Weinberg Group has compiled hundreds of 510(k) submissions to the FDA.  We have a proven track record of success and are highly qualified to assist in the process.
    • PMA Submission
      • As you know, this is the most rigorous and extensive of all device marketing applications. Don’t tackle it on your own. Let our team of knowledgeable consultants assist, leveraging 35 years of experience working with the FDA.
    • De Novo Request
      • It is no secret that the De Novo process can save you considerable amounts of time and money. However, preparing the submission can be difficult and confusing. We can help ensure you make the best case possible to help you obtain a De Novo determination.
    • HUD/HDE Submission
  • Regulatory Due Diligence

To learn more about Regulatory Strategy and Submissions,
contact us today.