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How MDR affected legislation of medical devices in European Union Member States

02.08.2022
MED Department
The two European regulations on medical devices: European Union Medical Device Regulation (EU MDR No. 2017/745) and In Vitro Diagnostic Regulation (EU IVDR No. ...
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GMP compliance in pharmaceutical industry – the importance of GMP regulations

05.07.2022
LD Department
Pharmaceutical industry is one of the most meticulously regulated ones in the world. It is not a surprise given that the patients’ well-being, including their ...
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How will the new EU GMP Annex 21 influence the importation of medicinal products?

14.06.2022
CMC Department
In February 2022 the European Commission published thenew Annex 21 to the EU ...
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Qualified Person in a nutshell: requirements, activities and responsibility of a QP

31.05.2022
CMC Department
Batch certification, GMP audtis, flow chain - what does Qualified Person really do?
- Read our article about QP service. ...
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