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Oncology Client A client came to us seeking oncology marketing authorisations for as many EU countries as possible. Over a two-year period, we concluded deals for 9 molecules and after running additional registrations the client had MA’s in 11 member states. IPG ran all the regulatory procedures, quality management and supply chain. What We Did In parallel, the client was constructing a new facility and IPG were engaged to oversee the engineering validation, quality compliance by locating team members in the facility for 3 weeks a month for two years. We successfully obtained EU GMP approval on first inspection with short corrective action plan – from a brown field through technical transfer to first tender supply in just over 4 years. Results We Achieved ICE Pharma Group (IPG) is a generic pharmaceutical company We concluded deals for 9 molecules. At conclusion, the client had MA’s in 11 member states. I am text block. Click edit button to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo. I am text block. Click edit button to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo. Work With Us If you are have a quality management or compliance project you need assistance with, get in touch with us to discuss your requirements and learn more about how we can help.
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Prezentacije s održanih edukacija prema temi Tinka Katić: Rad na Pravilniku za opis i pristup građi u knjižnicama, arhivima i muzejima Mirna Willer: Pravilnik za opis i pristup građi u knjižnicama, arhivima i muzejima: razvoj i opravdanost ideje o zajedništvu Ana Vukadin: Pravilnik za opis i pristup građi u knjižnicama, arhivima i muzejima: ciljevi, načela i struktura Ana Vukadin: Pravilnik za opis i pristup građi u knjižnicama, arhivima i muzejima: uvod Ana Vukadin: Pravilnik za opis i pristup građi u knjižnicama, arhivima i muzejima: implementacija u informacijskim sustavima Mirna Willer: Implementacija Pravilnika KAM u informacijskim sustavima: uvod Mirna Willer: Tehnologija povezanih podataka i ontologija za KAM elemente podataka I am text block. Click edit button to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.