Based on the current knowledge and our Team’s many years of experience in pharmaceutical form design and development as well as pharmaceutical analysis, we provide comprehensive services in the field of research and development of medicinal products.
We develop the following:
- formulations of innovative investigational medicinal products for clinical trials
- formulations of fixed-dose combinations
- modified release formulations
- drug delivery systems
- modified release formulations
- placebo formulations for clinical trials
We have a wealth of experience in the development of solid (tablets, powders, granules), semi-solid and liquid forms of medicinal products. As regards the most common drug form, namely tablets, we develop tablets with various release profiles, as well as ODT ones.
Depending on the requirements of our Clients, projects include the following steps:
- selection of suppliers of active substances
- preformulation studies
- formulation development
- increasing the solubility of active substances, e.g. by using a hot melt extrusion process in order to achieve amorphisation of the active substance
- optimisation of the technology developed and scale-up
- technology transfer to the production facility
- manufacturing of the (investigational) medicinal product, placebo in the GMP standard*
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.
We also offer development of formulations for in-vitro and in-vivo studies, as well as formulations for dietary supplements, special purpose foods and cosmetics.
* services provided in cooperation with Business Partners