Radiochemistry Services from A to Z
- Chemical path analysis for automation
- Automation feasibility assessment
- Draft automated process leading to first radioactive material
- Purification process (SPE or HPLC)
- Optimization – Robustness studies – final formulation report
- Analytical methods validation
- Consumables Technical File for production
- Manufacturing Transfer Plan
- Manufacturing Process Validation
- Stability study for shelf life
- Manufacturing Plan
- Consumables tests for release
- Sourcing & Logistics
- Change Control & complaint Management
- Technology transfer documentation
- Process Validation batches
- Doses Distribution
- Clinical Trials
ISO 13485 (in progress)