Billev Pharma East | Billev farmacija vzhod, registracija zdravil d.o.o.

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.

Let’s meet at the 13th Pharmacovigilance Conference

10.01.2020 Billev Pharma East is looking forward to attending the upcoming 13th Pharmacovigilance Conference in Amsterdam. Can you believe it has been almost a year since the previous annual Pharmacovigilance C... Read More

Approaching deadline for reporting the outcome of nitrosamine risk evaluations

09.01.2020 Risk evaluations that have been required for EU medicinal products, after potentially carcinogenic nitrosamines were identified in some classes of medicines, are still ongoing. MAHs are required to ... Read More

BPE can offer you a contractual PRRC for your Medical Devices

23.07.2019 Transitional period for the new EU legislation on Medical Devices that entered into force in May 2017 is getting close to an end. The industry must be prepared to implement the changes in accordance ... Read More