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).

Billev Pharma East will attend the 11th Pharmacovigilance Conference and lead a workshop on Management of Reference Safety Information ...

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 will attend CPhI worldwide on 24 – 26 October 2017, Messe Frankfurt, Germany: https://www.cphi.com/europe/.

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.