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