The Drug Product Development Unit consists of 8 highly experienced and skilled professionals, working in accordance with GLP, GCP and GMP regulations.
We provide solutions that enable turning the compounds which succeeded in in vitro and in vivo efficacy tests into the final medical product – ready to be used
in a clinical trials, conducted according to EMEA and ICH guidelines.
Our group is experienced both in generic and innovative drug product development including drug preformulations, excipients and API compatibility studies, product formulations as well as scaling-up, optimization and validation of manufacturing process. We also carry out formal stability studies of active substances and final products. The complete documentation of stability data is elaborated in the format compliant with EMEA standards. Finally, we create a part of regulatory submission documentation in CTD format.
Moreover, the Drug Product Development Unit is involved in development and validation of analytical methods applied to control raw materials, intermediate and final products. Pharmaceutical products require extensive material testing to confirm the quality and physicochemical properties. Thus, the quality assurance program is very important element of our assignments.
Medicinal Chemistry Unit
Laboratory of Molecular Biology and Preclinical Research
Our group is experienced both in generic and innovative drug product development including drug preformulations, excipients and API compatibility studies, product formulations as well as scaling-up, optimization and validation of manufacturing process. We also carry out formal stability studies of active substances and final products. The complete documentation of stability data is elaborated in the format compliant with EMEA standards. Finally, we create a part of regulatory submission documentation in CTD format.
Moreover, the Drug Product Development Unit is involved in development and validation of analytical methods applied to control raw materials, intermediate and final products. Pharmaceutical products require extensive material testing to confirm the quality and physicochemical properties. Thus, the quality assurance program is very important element of our assignments.
Medicinal Chemistry UnitLaboratory of Molecular Biology and Preclinical Research
Celon Pharma Ltd
ul. Ogrodowa 2A
05-092 Lomianki, Kielpin
ul. Ogrodowa 2A
05-092 Lomianki, Kielpin
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Designed by GREGMAR