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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.
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…
Risk evaluations that have been required for EU medicinal products, after potentially carcinogenic nitrosamines were identified in some classes of medicines, are still ongoing.
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.
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…
New versions of electronic Applications Forms for marketing authorisation applications, renewals and variations for human and veterinary medicines have been released.
New versions of electronic Applications Forms for marketing authorisation applications, renewals and variations for human and veterinary medicines have been released.
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..
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).
Billev Pharma East will attend the 11th Pharmacovigilance Conference and the 17th Regulatory and Scientific Affairs Conference on 24th-26th of January in London.
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).
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.
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.
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.
