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Submissions and documents we can help with
Regulatory submissions are cross-functional endeavors. Many of the documents within each submission require teamwork between several of our departments, including Regulatory Affairs, Drug Development and Biostatistics.
- Clinical Trial Application (CTA)
- Investigational New Drug Application (IND)
- Orphan Drug Designation (ODD)
- Pediatric plans (PIP/iPSP)
- Fast Track and Breakthrough Therapy Designation
- Priority Medicines (PRIME)
- Market Authorization Application (MAA)
- New Drug Application (NDA)
- Biologics License Applications (BLA)
