Services offer

F1 Pharma provides complex drug product development that covers:

  • literature and patent search for nominated drug products
  • execution of necessary preformulation studies
  • selection of active pharmaceutical ingredients, excipients and packaging materials
  • suppliers qualification
  • performance and optimization of technological trials, including determination of critical parameters for the developed process
  • development and validation of analytical methods
  • planning and supervision of pilot batches manufacturing
  • stability and photostability studies according to ICH guidelines in long-term, intermediate and accelerated storage conditions
  • analytical method transfer
  • evaluation of technological and analytical documentation
  • preparation of documentation for process of registration (Module 3 – Quality)