News

Medical translations

18.09.2020 Contact us if you need to be assured that your translations intended for healthcare professionals and patients are prepared by experts understanding the implications behind and medical language. https... Read More

BPE offers you a PRRC for your Medical Devices

03.09.2020 Medical device manufacturers should be aware of obligations laid down in Article 15 of the MDR where there is requirement for person responsible for regulatory compliance (PRRC) which also checks conf... Read More

Billev Pharma East was managing the whole decentralized regulatory procedure to gain approval

02.09.2020 Please check LinkedIn for more information.... Read More

GCP AUDITS

22.06.2020 We are proud to announce the availability of our GCP auditor, experienced and trained to perform independent audits and deliver audit report. As our GCP auditor is also a medical and pharmacovigilance... Read More

ENVIRONMENTAL RISK ASSESSMENT (ERA)

12.06.2020 BILLEV PHARMA EAST can deliver an export report on ERA with strategy for development of ERA, required calculations and justifications in accordance with the guidelines. ERA as part of the marketing au... Read More

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

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