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18
August
2021
Schedule a meeting with Alenka.
26
May
2021

MDR

Medical Device Regulation comes into application on 26th of May 2021.
06
May
2021
Will EFSA assessment impact medicinal products? EMA quality working group is organizing a meeting with industry on 10 June.
18
September
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
12
June
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.
22
April
2020
We are proud to announce the availability of our GCP auditor, experienced and trained to perform independent audits and deliver audit report.
09
March
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…
10
January
2020
Billev Pharma East is looking forward to attending the upcoming 13th Pharmacovigilance Conference in Amsterdam.
09
January
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.
23
July
2019
Transitional period for the new EU legislation on Medical Devices that entered into force in May 2017 is getting close to an end.
29
March
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.
24
February
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…
13
February
2019
In January we attended the 12th Pharmacovigilance Conference and 18th Regulatory and Scientific Affairs Conference
06
February
2018
New versions of electronic Applications Forms for marketing authorisation applications, renewals and variations for human and veterinary medicines have been released.
06
February
2018
New versions of electronic Applications Forms for marketing authorisation applications, renewals and variations for human and veterinary medicines have been released.
05
February
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..
05
February
2018
We recently attended a pharmacovigilance and regulatory conference which is organised annually by European…
30
January
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 Research (CBER).
09
January
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.
15
December
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).
23
November
2017
Billev Pharma East will attend the 11th Pharmacovigilance Conference and lead a workshop on Management of Reference Safety Information …
13
November
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 in the eSubmission Roadmap.
08
November
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 detection to implementation.
16
September
2017
Billev Pharma East will attend CPhI worldwide on 24 – 26 October 2017, Messe Frankfurt, Germany: https://www.cphi.com/europe/.
16
September
2017
Billev Pharma East is prepared and up to date to support you with the regulatory and pharmacovigilance implications related to ‘hard’ BREXIT, being part of the task force.
13
September
2017
Billev Pharma East can help you to calculate Health-Based Exposure Limits (HBELs) in the context of quality risk management of cross contamination…