F1 Pharma offers:
- development of analytical procedures using chromatographic methods, spectrophotometric methods and other techniques based on classical analysis for active substances and final drug products.
- validation of analytical methods in accordance with ICH, FDA and EMA guidelines
- analytical method transfer to target/client laboratory
- rate of dissolution (dissolution profiles) of active substances from various drug forms
- analysis of physicochemical properties for active substances (DSC, TGA, XRPD, SEM imaging, particle size distribution)
- reological studies, texture analysis
- compatibility studies for formulation components
- determination of impurity profiles, characterization of impurities, identification of unknown impurities and degradation products
- evaluation of analytical documentation in accordance with GMP and regulatory affairs requirements
- consultancy in scope of analytical method development and preparation of documentation for registration purposes