Development of analytical methods that allow for reliable assessment of the quality of the products obtained forms an integral part of work in the area of chemical synthesis and development of formulations of medicinal products.
Based on the current knowledge and our Team’s many years of experience in pharmaceutical analysis, we provide R&D work including the following:
- identification and quantification (or characterisation) of impurities
- physical and chemical characterisation of active and test substances
- support in the scope of selecting suppliers of active substances, including verification of documentation and analysis of samples of active substances
- verification of analytical methods
- development of analytical methods
- validation of analytical methods
- development and optimisation of release testing conditions
- transfer of analytical methods to the production facility
- stability testing (initial and GMP*)
- preparation of the relevant sections of regulatory documents (Investigational Medicinal Product Dossier, Module 3)
- production facility audits
We implement all projects in accordance with current knowledge and regulatory requirements, to meet the highest standard of research.
* services provided in cooperation with Business Partners