We offer you scientific solutions with beneficial impact on your business processes to gain competitive advantage.

Regulatory Affairs

We will help you to foresee the bottleneck situations and fulfil the requirements so your products are lawfully and timely placed on the market.

Pharmacovigilance

We have the PhV systems and qualified persons to help you comply with the complex safety standards.

Medical Consultancy

We offer you expertise in medical writing in clinical, non-clinical and pharmacovigilance areas.

Latest news

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