Clinical Supplies from your (or our) development
Analytical service and documentation
- Development and validation of analytical method (ICH/CPMC)
- Lab to lab-transfer
- Quality control and process-validation
- Analytical and bioanalytical examinations of medicinal test- and reference products under GMP-conditions (in vitro / in vivo-performance)
- Screening of packaging material under accelerated conditions
- Stability testing and defining the shelf-life / retesting date of clinical supplies
- EU-release of medicinal products / comparator products from non-EU-countries
- Medical writing: IMPD