While our primary focus is on submissions to the US Food and Drug Administration (FDA) and Health Canada, our experts have authored and/or reviewed registration dossiers submitted to the European Medicines Agency, MHRA, TGA, and several global health authorities (HAs).
- We have authored, reviewed, and evaluated multiple regulatory submissions including:
- Investigational New Drug Applications (INDs)
- Clinical Trial Applications (CTAs)
- New Drug Applications – 505(B)(1) and 505(B)(2)
- New Drug Submissions (NDS)
- Marketing Authorization Applications (MAA)
- Responses to FDA and HA requests for information
- We have led and/or supported multiple FDA-sponsor meetings including:
- Pre-IND meetings
- End-of-Phase II meeting
- Pre-NDA and Pre-NDA CMC meetings
- Meetings to address Complete Responses from the FDA and other global HAs