What we deliver
- MHRA Combined Review (CTA) and IRAS submissions
- EU CTR submissions via CTIS
- FDA IND preparation and submission support
- IMPD compilation and lifecycle maintenance
- Ethics committee and HRA approvals
- Substantial amendments and annual safety reports
Why it matters
- First-time approval rates above industry average
- Reduced clock-stops and RFI cycles
- Single point of contact across multiple jurisdictions
