ATMP (Cell and Gene Therapy) Regulatory Support
The team at Diamond Pharma Services has world class regulatory experience in assisting companies developing advanced therapy medicinal products (ATMPs). Support can be provided for both cell and gene therapy products for Europe and the US.
Diamond have supported more than 35 different gene and cell therapy development programmes in the last 10 years. These programmes contain a diverse set of ATMP technologies including various viruses and vector types, oncolytic viruses and an increasing number of gene modified cell therapy modalities.
Key services offered:
- National and EMA scientific advice meetings
- Regulatory GAP analysis and development plans
- SME status applications
- Prime applications
- Orphan designation applications
- Paediatric investigation plans
- CTA and IND support
- MAA / BLA
- US agent
- FDA meeting support.