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)