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.
Regulatory Consulting
Regulatory Strategy
Your regulatory strategy should be different for each product and indication, and should be formulated with your business objectives in mind. As experts in FDA regulatory consulting, ClinPro Trials Regulatory Experts will work with you to develop an appropriate and effective strategy to get your product to market. Our team will combine knowledge of your product with years of experience (including pre-clinical, clinical, CMC, drug safety, and pharmacokinetics) and literature research on your product and similar approvals. The final regulatory strategy for your product will balance risk, speed to approval, and cost to provide you with a description of the most appropriate regulatory path and explain why this path is the rational choice.
Whether you need help executing your entire regulatory strategy, producing an FDA briefing package, or conducting a Pre-IND Meeting, ClinPro Trial’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. We can help you:
- Development of the regulatory strategy and submission plan to support both US and “Global” registrations
- Explore the possibility of pursuing expedited pathways (e.g. Priority Review, Breakthrough Designation, etc).
- Prepare and review regulatory agency meeting requests and packages
- Attend regulatory agency meetings
- Create non-clinical development plans
- Prepare for and participate in FDA Advisory Committee meetings
FDA Meetings
To achieve your goals at a meeting with the FDA, the interaction must be carefully planned and executed flawlessly, leaving the FDA with a good impression of your product and company. This requires experts with prior regulatory experience who know the appropriate time to request a meeting, what is needed to prepare the necessary paperwork, what to expect when meeting with the FDA, and what steps should be taken post-meeting.The FDA meetings we can provide assistance to you include:
1. 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.
2. 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.
3. Pre-IND Meeting
The intent of the Pre-NDA Meeting, you should have an understanding of the FDA’s expectation for the content to be included in the NDA. During the Pre-NDA Meeting, we will 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
4.FDA Advisory Committee Meeting
ClinPro Trials will partner with you to execute a flawless FDA Advisory strategy committee meeting.