Billev Pharma East can help you with QP release and GMP audits preparation

29.03.2019 Billev Pharma East is aware that finding a suitable QP represents a huge challenge for many pharmaceutical companies and has the expertise to help you. Our QP is trained in applicable legislation and ... Read More

Are you ready for Brexit?

24.02.2019 There are still so many uncertainties concerning Brexit, however, the currently planned date of UK withdrawal (‘hard Brexit scenario’) is approaching at a high speed. In case there is no w... Read More

Billev Pharma East at the annual Pharmacovigilance and Regulatory Affairs Conference 2019

13.02.2019 In January we attended the 12th Pharmacovigilance Conference and 18th Regulatory and Scientific Affairs Conference in London organized by European stakeholder association Medicines for Europe. The pha... Read More

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

PhV and RA conference in London from 24th-26th of January

09.01.2018 Billev Pharma East will attend the 11th Pharmacovigilance Conference and the 17th Regulatory and Scientific Affairs Conference on 24th-26th of January in London. You can visit us on our booth and disc... Read More

SPOR going live 15 December 2017

14.12.2017 Billev Pharma East is ready for the first phase of SPOR implementation with first services to go live: OMS (Organisations management service) and RMS (Referentials management service). The portal is b... Read More

Let’s meet at the 11th Pharmacovigilance Conference

23.11.2017 Billev Pharma East will attend the 11th Pharmacovigilance Conference and lead a workshop on Management of Reference Safety Information which is a challenge for the pharmaceutical industry from detecti... Read More

NeeS is out from MRP (eCTD only for all submissions in EU procedures) from 1 January 2018

13.11.2017 We in Billev Pharma East are ready for many years. Pharmaceutical companies will no longer be able to submit MRP (mutual recognition procedure ) applications in the NeeS submission format, as outlined... Read More