Accelerate your cell or gene therapeutic to market with tailored clinical and regulatory strategies and expert insights.
We understand how high the stakes are with your advanced cell or gene therapy program. Nothing is standard about study design, study conduct, or regulatory process in this specialized area. Castel Laboratories has successfully supported over 100 cell and gene therapy programs with a global team of scientific experts who are adept at both strategy and execution across the clinical development journey.
- >100 cell and gene therapy programs
- >20 submissions including MAA, BLA, IND, CTA
- 3 Marketing Application Approvals to date
- 65% of programs for rare diseases
- Executed trials for the first gene therapy approved in Europe