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 and its sister agencies 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
- FDA Submissions
- Regulatory Due Diligence