How To Tell If You Need A Regulatory & Compliance Consulting Service?
Ever feel like the FDA/EMA (pick your acronym) was just running all over you? Or that the maze of regulations needing to be navigated was just too thick? Maybe that next milestone is very critical to your funding and getting there seems a bit challenging? Perhaps you have too many consultants or too few or the ones you have just provide cookie cutter results?
Each of these scenarios is exactly why clients call us. Our response is to meet those milestones cost-effectively and get you to the next step in your development process. Our expert regulatory affairs and compliance consultants do this by telling you exactly what you need to know—not necessarily what you want to hear—but the reality of the situation you face. We let you know what the real budget is and how long it will really take to get where you want to go.
Why Choose The Weinberg Group?
For over 33 years, The Weinberg Group has made sure clients like you achieve their drug and device development goals. We have spent more time figuring out what you need than most firms have spent in business. Along the way, we have developed the relationships required to get your product through to the next step.
Our Consulting Services Include:
- Outsourced Regulatory Affairs
- Project-Based Regulatory Strategy and Submissions
- Regulatory Strategy Consulting
- FDA Meetings (including the Pre-IND Meeting, End of Phase 2 Meeting, Pre-NDA Meeting, FDA Advisory Committee Meeting)
- FDA Submissions (including IND Submission, NDA Submission: 505(b)(1) and 505(b)(2) Assistance, Orphan Designation, ANDA Submission)
- Regulatory Due Diligence
- Quality & Compliance