Pharmazeutische und chemische Entwicklungsgesellschaft mbH Formula-Pharma
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