Identifying the right regulatory strategy from the outset is key and this starts before any patient has even entered a clinical trial. We can help to develop the best suitable regulatory strategy, apply for orphan drug designations in the US and Europe, prepare for and attend at FDA & EMA meetings, and advise on establishing relations to important patient advocacy groups. We have assisted many biotech companies in the past who have avoided moving into the wrong direction and paying for it further down the line.
- Regulatory Strategy Planning
- Orphan Designation Applications
- Break Through Designation Applications
- Pediatric Priority Review Vouchers
- FDA and EMA Meeting Preparation and Representation
- Patient Advocacy Group strategic planning