PrimeVigilance stands at the forefront of the burgeoning Cell and Gene (CGT) / Advanced Therapy Medicinal Products (ATMPs) sector, providing specialized and comprehensive support to organizations navigating this complex field.
Our dedicated business unit harnesses the expertise from over 50 clients’ research endeavors to ensure success in CGT/ATMP development.
Talk to an Expert Download the CGT/ATMP detailed service info sheet
What we deliver
End-to-end safety & PV support, tailored to your program needs and resourcing model:
- Full ICSR processing (unique workflows that acknowledge the high regulatory scrutiny and need for completeness in first regulatory submission)
- PV project management and operational delivery
- Safety medical writing (e.g., DSUR, PBRER, RMP)
- Clinical Trial Safety, SMPs, SDEAs, Joint-Guides & Medical Monitoring
Flexible delivery
We provide custom, scalable solutions supported by global systems and configurable processes, with onshore/offshore resourcing and dedicated, hybrid, or shared team options.
Experience
Our CGT/ATMP engagement includes support across multiple therapeutic areas and phases, with ongoing post-authorisation safety profile management.
- 50+ clients
- 60+ clinical trials supported in the last 24 months
- 10+ Project Managers with CGT/ATMP experience
- Strategic and local pharmaceutical regulatory affairs expertise
Clients choose PrimeVigilance for CGT/ATMP programs because we combine specialist expertise, flexible delivery, technology-enabled operations, and a patient-centred approach that supports consistent, high-quality safety execution.
