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Updates to eAFs

06.02.2018 New versions of electronic Applications Forms for marketing authorisation applications, renewals and variations for human and veterinary medicines have been released. The main changes include the impl... Read More

Billev Pharma East experience from conference in London

05.02.2018 We recently attended a pharmacovigilance and regulatory conference which is organised annually by European stakeholder association Medicines for Europe whose member is also Billev Pharma East d.o.o.. ... Read More

FDA’s May 2018 eCTD deadline

30.01.2018 The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Rese... Read More