OUR SERVICES
Regulatory
Aroga's document types include (but are not limited to):
- Clinical CTD summary documents for marketing applications (eg, NDAs and BLAs)
- INDs
- Regulatory Responses
- Briefing Packages
- Pediatric Study Plans/Pediatric Investigational Plans
- Orphan drug applications/European Orphan Medicinal Product Designation (OMPD)
