Kapaji s.r.o.

Opis działalności:

Kapaji s.r.o. was created in 2019. Kapaji is independent team of hands-on industrial experts with many years of practical experience mainly in generic API and drug product development. We are offering end-to-end drug product development (from preformulation trials, through lab development, GMP optimization up to dossier writing). We combine technical project management with technical skills and standard and non-standard state-of-the-art equipment. We are working for many CMOs as „troubleshooters”. If you need advanced API, excipients or drug product analyses, please let us know – check lab.kapaji.eu.

Are you looking for special competencies like computerized system validation or toxicological evaluation (extractables and leacheblas, ERA, tox assessments), please, let us know: pavel@kapaji.eu

Do you need practical trainings in specific areas, please, check our web.

Our key competencies:

Reverse engineering (quantitative composition of excipients for BCS biowaiver, API PSD estimation in DP, formulation process estimation)

Troubleshooting (OOS results, unknown impurity identification, API or excipients suppliers comparison, etc.)

Method development and validation

Advanced in vitro testing – extensive test vs reference comparison before clinical trials

Advanced API physchem characterization (surface area and energy, hygroscopicity, chemical degradation, etc.)

Advanced granules characterization ( porosity, surface area, plasticity, elasticity, agglomeration, flowability, etc.

Drug product development on small-scale

Technical project management

IP

Toxicology

Computerized system validation