Specialist add-on · Toolkit B
Cell & Gene Therapy / ATMP Add-On
Extend the core system with ATMP-specific regulatory, identity, custody, long-term follow-up, CMC, and source-traceability controls.
What it helps control
Operational support
Helps teams maintain traceability and decision evidence across the specialised risks of cell and gene therapy development.
How it helps your team
Add product-specific controls without rebuilding the core development system.
Designed for
ATMP development, CMC, clinical, supply chain, safety, Quality, and Regulatory Affairs teams.
Included files
Know exactly what the toolkit contains
The file names below show what is included. File contents become available only after purchase.
Word documents
- ATMP Regulatory Strategy
- Chain of Identity Procedure
- Chain of Custody Procedure
- Long-Term Follow-Up Safety Plan
- ATMP CMC Control Strategy
- Vector / Cell Source Traceability Plan
Excel workbooks
- Chain of Identity Tracker
- Chain of Custody Tracker
- ATMP Risk Register
- LTFU Tracker
- Vector / Cell Source Traceability Tracker
Related toolkits
Continue within specialist add-on
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Extend the core development system with biologics-specific CMC, immunogenicity, species relevance, comparability, viral safety, and potency controls.
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Extend the core system with oncology-specific dose escalation, DLT, response assessment, combination risk, and safety-review controls.
DPaediatric Development Add-On
Extend the core system with paediatric planning, commitments, consent and assent, safety monitoring, and age-appropriate formulation controls.